Annuloplasty technologies

ABSTRACT

An anchor includes (a) an anchor head; and (b) a tissue-engaging member extending distally away from the anchor head until a distal tip of the tissue-engaging member, and configured to anchor the anchor to tissue. An anchor driver can include (a) a longitudinal shaft, having a flexible distal portion and a distal end; (b) a deployment element at the distal end of the shaft, reversibly lockable to the anchor head, and reversibly movable between (i) a locked state that retains locking between the deployment element and the anchor head, and (ii) an unlocked state that unlocks the deployment element from the anchor head; and (c) a tissue-piercing lance, reversibly movable between (i) an extended state in which the lance extends distally from the shaft past the distal tip of the anchor, and retains the deployment element in the locked state, and (ii) a retracted state in which the deployment element automatically moves into the unlocked state.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent applicationSer. No. 15/782,687 to Iflah et al., entitled “AnnuloplastyTechnologies,” filed Oct. 12, 2017 (now U.S. Pat. No. 10,765,514), whichis a Continuation of PCT patent application IL2016/050433 to Iflah etal., entitled “Annuloplasty Technologies,” filed Apr. 21, 2016, whichpublished as WO 2016/174669, and which claims priority from U.S.Provisional Patent Application 62/154,962 to Reich et al., entitled“Annuloplasty Technologies,” filed on Apr. 30, 2015, which isincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair, and morespecifically to repair of an atrioventricular valve of a subject.

BACKGROUND

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

SUMMARY OF THE INVENTION

In some applications of the present invention, a multi-component tubularsystem is provided for accessing a heart of a subject. The systemcomprises one or more steerable guiding catheters configured fordirecting the passage of devices therethrough into the heart. Themulti-component tubular system is configured to deliver an implant in adesired orientation to an annulus of a cardiac valve of the subject andto facilitate anchoring of the implant to the annulus. For someapplications of the present invention, the guiding system is advancedtransluminally or transthoracically accessing an atrium of the heart.Typically, the system comprises two or more steerable catheters. A firstcatheter has a distal portion that is steerable to a first desiredspatial orientation. A second catheter is disposed within the firstcatheter and has a distal portion that is steerable to a second desiredspatial orientation. The system provides techniques andrelative-spatial-orientation-controlling devices for controlling theorientation of the distal portion of the second catheter with respect tothe first catheter without substantially distorting the first spatialorientation of the distal portion of the first catheter.

For some applications, an implant is advanced via the multi-componentcatheter system, and is anchored to tissue of the subject by driving oneor more tissue anchors through a channel using an anchor driver. Forsome applications, the anchor driver is used to provide a referenceforce to a recently-anchored anchor, while the implant is furtherexposed from the catheter system. For some applications, a first tissueanchor has a tissue-coupling element that is wider than thetissue-coupling element of subsequent anchors, and is wider than thechannel. For some applications, a lance is used to control anchoring ofthe tissue anchors.

For some applications, the implant has a contraction member that extendsfrom an adjustment mechanism, along the implant, and back again.

For some applications, a system is provided for repeatedly docking withand adjusting an adjustment mechanism of the implant.

For some applications, the multi-component catheter system comprises aforce gauge for testing the anchoring strength of individual anchorssubsequent to their anchoring.

Other embodiments are also described.

There is therefore provided, in accordance with an application of thepresent invention, apparatus, for use with a tissue of a subject, theapparatus including:

an anchor, including:

-   -   an anchor head, and    -   a tissue-engaging member, coupled to the anchor head, extending        distally away from the anchor head until a distal tip of the        tissue-engaging member, and configured to anchor the anchor to        the tissue;

an anchor driver, including:

-   -   a longitudinal shaft, having a flexible distal portion and a        distal end,    -   a deployment element at the distal end of the shaft, reversibly        lockable to the anchor head, and reversibly movable between (i)        a locked state that retains locking between the deployment        element and the anchor head, and (ii) an unlocked state that        unlocks the deployment element from the anchor head, and    -   a tissue-piercing lance, reversibly movable between:        -   an extended state in which (i) the lance extends distally            from the shaft, (ii) while the deployment element is locked            to the anchor head, the lance extends distally past the            distal tip of the anchor, and (iii) the lance retains the            deployment element in the locked state, and        -   a retracted state in which the deployment element            automatically moves into the unlocked state.

In an application, in the retracted state, the lance does not extenddistally past the distal tip of the anchor.

In an application, in the retracted state, the lance does not extenddistally from the shaft.

There is further provided, in accordance with an application of thepresent invention, apparatus, for use with a tissue of a subject, theapparatus including:

a percutaneous catheter;

an implant, dimensioned to be advanced into the subject via thecatheter;

an anchor-delivery channel, shaped to define a lumen therethrough, thelumen having a diameter, and the channel being dimensioned to bedisposable within the catheter;

at least one anchor, including an anchor head coupled to atissue-coupling element, the anchor head defining an aperturetherethrough, and

an anchor driver:

-   -   including a stem, and a driver head coupled to the distal end of        the stem, the driver head being reversibly couplable to the        anchor head,    -   configured to advance the anchor through the lumen of the        channel while the driver head is coupled to the anchor head,    -   further including a lance that is reversibly extendable with        respect to the driver head, such that when the driver head is        coupled to the anchor head, extension of the lance causes the        lance to slide through the aperture such that a tip of the lance        becomes disposed distally beyond a distal tip of the        tissue-engaging element, and    -   configured to drive the tip of the lance through a portion of        the implant and into the tissue of the subject, and to drive the        tissue-coupling element of the anchor through the portion of the        implant and into the tissue of the subject, independently of the        driving of the tip of the lance.

There is further provided, in accordance with an application of thepresent invention, apparatus, for use with a tissue of a subject, theapparatus including:

an anchor, including:

-   -   an anchor head, having a proximal side and a distal side, and        defining an aperture from the proximal side to the distal side,    -   a tissue-engaging member, coupled to the anchor head, extending        distally away from the anchor head until a distal tip of the        tissue-engaging member, and configured to anchor the anchor to        the tissue;

an anchor driver, including:

-   -   a longitudinal shaft, having a flexible distal portion and a        distal end,    -   a tissue-piercing lance, reversibly extendible distally from the        shaft,    -   a deployment element coupled to the distal end of the shaft, and        reversibly couplable to the anchor head in a position in which        extension of the lance distally from the shaft moves the lance        through the aperture and past the distal tip of the anchor; and

a catheter system, including:

-   -   a catheter:        -   through which the anchor driver is intracorporeally            advanceable (i) while the deployment element is coupled to            the anchor head, and (ii) such that the distal portion of            the shaft extends distally out of the catheter, and        -   having a distal segment that is intracorporeally deflectable            with respect to another segment of the catheter immediately            proximal to the distal segment, and    -   an extracorporeal controller configured, while the distal        portion of the shaft is extended distally out of the catheter,        and the lance is extended distally from the shaft and is        disposed in the tissue, to cause deflection of the distal        segment with respect to the other segment, such that the distal        portion of the shaft deflects with respect to another portion of        the shaft immediately proximal to the distal portion,        the anchor driver being configured to drive the tissue-engaging        member into the tissue while the distal portion of the shaft is        deflected with respect to the other portion of the shaft.

There is further provided, in accordance with an application of thepresent invention, a method, including:

advancing a distal end of an anchor driver through a catheter and towarda tissue of a subject, the anchor driver including a shaft, atissue-piercing lance, and a deployment element;

subsequently, piercing the tissue with the lance;

deflecting a distal portion of the shaft with respect to another portionof the shaft immediately proximal to the distal portion, by moving adistal segment of the catheter while at least some of the lance isdisposed within the tissue; and

while (i) the distal portion of the shaft is deflected with respect tothe other portion of the shaft, and (ii) the deployment element islocked to a head of an anchor, driving a tissue-engaging member of theanchor into the tissue using the anchor driver.

There is further provided, in accordance with an application of thepresent invention, a method for use with an implant, the methodincluding:

using an implant-manipulating handle, coupled to the implant, topercutaneously advance the implant through a catheter toward an implantsite of a subject;

by applying a first force to the implant-manipulating handle, slidingthe implant with respect to the catheter without causing the implant toapply force to tissue at the implant site;

measuring a magnitude of the first force;

subsequently, anchoring the implant to tissue at the implant site;

subsequently, by applying a second force to the implant-manipulatinghandle, causing the implant to apply a third force to tissue at theimplant site via the anchoring of the implant;

measuring a magnitude of the second force; and

determining a magnitude of the third force at least in part responsivelyto a difference between the magnitude of the first force and themagnitude of the second force.

In an application, sliding the implant by applying the first force tothe implant-manipulating handle includes sliding the implant proximallywith respect to the catheter by applying the first force to theimplant-manipulating handle.

In an application:

measuring the magnitude of the first force includes measuring themagnitude of the first force using a force gauge,

measuring the magnitude of the second force includes measuring themagnitude of the second force using the force gauge, and

the method further includes, subsequently to measuring the magnitude ofthe first force and prior to causing the implant to apply the thirdforce, zeroing the force gauge to the magnitude of the first force.

In an application:

the anchor-manipulator handle includes a force gauge,

measuring the magnitude of the first force includes measuring themagnitude of the first force using the force gauge, and

measuring the magnitude of the second force includes measuring themagnitude of the second force using the force gauge.

In an application, anchoring the implant includes anchoring the implantby driving a tissue anchor into tissue at the implant site.

In an application, causing the implant to apply the third force byapplying the second force to the implant-manipulating handle includes,by applying the second force to the implant-manipulating handle, causingthe implant to apply the third force via the tissue anchor.

There is further provided, in accordance with an application of thepresent invention, apparatus, including:

a percutaneously-implantable implant;

an adjustment device, including:

-   -   an adjustment mechanism, coupled to the implant, and configured        to change a dimension of the implant upon actuation of the        adjustment mechanism; and    -   a lock:        -   having a locked state in which the lock inhibits actuation            of the adjustment mechanism,        -   having an unlocked state in which the adjustment mechanism            is actuatable, and        -   reversibly movable between the locked state and the unlocked            state;

a longitudinal guide member; and

an adapter:

-   -   coupled to the guide member,    -   including a fastener that couples the adapter to the adjustment        device, and is intracorporeally decouplable from the adjustment        device,    -   configured to be percutaneously delivered while coupled to the        adjustment device, and    -   including an unlocking mechanism, configured such that, while        the adapter is coupled to the adjustment device, actuation of        the unlocking mechanism moves the lock between the locked state        and the unlocked state.

In an application, the actuation of the unlocking mechanism moves thelock from the locked state to the unlocked state by the unlockingmechanism pressing on a depressible portion of the lock.

In an application, the unlocking mechanism includes a pin disposed in achannel, and the actuation of the unlocking mechanism that moves thelock from the locked state to the unlocked state includes sliding of thepin within the channel.

In an application, the fastener is shaped to define at least part of thechannel.

In an application:

the adjustment device is shaped to define a first screw thread, and

the fastener (i) is shaped to define a second screw thread that couplesthe fastener to the adjustment device by engaging the first screwthread, and (ii) is intracorporeally decouplable from the adjustmentdevice by the second screw thread being unscrewed from the first screwthread.

In an application, the lock is biased to be in the locked state in theabsence of the pressing of the depressible portion.

In an application, the apparatus further includes an adjustment tool,and the adjustment tool:

is percutaneously advanceable along the guide member to the adapter,subsequently to implantation of the implant,

includes an adjustment-mechanism interface, dimensioned to interfacewith the adjustment mechanism,

includes an adapter interface, dimensioned to interface with theadapter, and including an force applicator, and

is configured:

-   -   to move the lock into the unlocked state by, while the adapter        is coupled to the adjustment device, actuating the unlocking        mechanism by applying, with the force applicator, a force to the        unlocking mechanism, and    -   to actuate the adjustment mechanism via the interface between        the adjustment-mechanism interface and the adjustment mechanism.

In an application, the tool is configured to decouple the adapter fromthe adjustment device.

In an application, the adjustment-mechanism interface and the adapterinterface are independently controllable.

In an application, the tool is configured to decouple the adapter fromthe adjustment device independently of actuating the unlockingmechanism.

In an application, the force applicator is axially slidable with respectto the adapter, and is configured to actuate the unlocking mechanism byapplying an axial force to the unlocking mechanism.

In an application:

the adapter includes a trunk that is shaped to define a channel,

the unlocking mechanism includes the channel, and a pin disposed andslidable within the channel, and

the force applicator is configured to actuate the unlocking mechanism bysliding the pin within the channel by applying an axial force to thepin.

In an application, the trunk is shaped to define a lateral opening, thepin includes an appendage that protrudes laterally out of the opening,and the adapter interface is dimensioned to be slidable over a proximalportion of the trunk to a sufficient extent that the force applicatorreaches the appendage.

In an application, a transverse cross-section of the proximal portion ofthe trunk has an external shape that is non-circular, and the tool isconfigured to decouple the adapter from the adjustment device byapplying torque to the trunk via the adapter interface.

In an application, a distal portion of the adapter interface is angledsuch that, in response to sliding of the adapter interface axially overthe proximal portion of the trunk, the adapter interface automaticallyassumes a pre-determined rotational orientation with respect to thetrunk.

In an application, the distal portion of the adapter interface is angledsuch that in the pre-determined rotational orientation the forceapplicator is aligned with the appendage.

In an application, the force applicator is angled such that, in responseto sliding of the adapter interface axially over the proximal portion ofthe trunk, the adapter interface automatically assumes a pre-determinedrotational orientation with respect to the trunk.

In an application, the distal portion of the adapter interface is angledsuch that in the pre-determined rotational orientation the forceapplicator is aligned with the appendage.

In an application, while the adapter interface assumes thepre-determined rotational orientation in which the force applicator isaligned with the appendage, the non-circular shape of the proximalportion of the trunk inhibits the adapter interface from rotatingfurther in response to further sliding of the adapter interface axiallyover the trunk.

In an application, the trunk is shaped to define one or more shouldersthat are angled such that, in response to sliding of the adapterinterface axially over the shoulders, the adapter interfaceautomatically assumes a pre-determined rotational orientation withrespect to the trunk.

In an application, the distal portion of the adapter interface is angledsuch that in the pre-determined rotational orientation the forceapplicator is aligned with the appendage.

There is further provided, in accordance with an application of thepresent invention, apparatus, for use with a tissue of a subject, theapparatus including an annuloplasty structure, the annuloplastystructure including:

a sleeve, having a first end and a second end, a bearing site, andincluding a lateral wall that defines a lumen from the first end to thesecond end,

an adjustment mechanism, and

a contraction member:

-   -   having a first end coupled to the adjustment mechanism,    -   having a first portion that extends from the adjustment        mechanism along the sleeve toward the second end, until the        bearing site, and    -   having a second portion that extends from the bearing site back        toward the adjustment mechanism and the first end,        the adjustment mechanism being configured to reduce a length of        the sleeve between the first end and the second end by pulling        on the first portion of the contraction member such that the        second portion of the contraction member progressively slides        past the bearing site.

In an application, the first portion weaves through the lateral wall ofthe sleeve.

In an application, the second portion weaves through the lateral wall ofthe sleeve.

In an application, the first portion passes along the lumen.

In an application, the second portion passes along the lumen.

In an application, the contraction member has a second end that isfixedly coupled to the sleeve.

In an application, the sleeve has a hole therein, the hole defining thebearing site, the contraction member being slidable through the hole.

There is further provided, in accordance with an application of thepresent invention, a method, including:

percutaneously advancing toward a tissue of a subject an implantincluding a sleeve that defines a tubular lateral wall and a lumen,while a distal portion of an anchor-delivery channel is disposed withinthe lumen, such that a distal opening of the channel is disposed at afirst portion of the sleeve;

anchoring the first portion of the sleeve to a first tissue site byusing an anchor driver to drive a tissue-coupling element of a firstanchor through the distal opening of the channel, through the lateralwall at the first portion of the sleeve, and into the first tissue site;

pressing a second portion of the sleeve against a second tissue site;and

anchoring the second portion of the sleeve to a second tissue site bydriving a tissue-coupling element of a second anchor from outside thelumen, through opposing sides of the lateral wall at the second portionof the sleeve, and into the second tissue site.

In an application, pressing the second portion of the sleeve against thesecond tissue site includes pressing the second portion of the sleeveagainst the second tissue site such that the opposing sides of thelateral wall at the second portion of the sleeve contact each other.

In an application:

the implant includes an annuloplasty structure that includes the sleeve,

anchoring the first portion of the sleeve to the first tissue siteincludes anchoring the first portion of the sleeve to an annulus of anatrioventricular valve of a heart of a subject, and

anchoring the second portion of the sleeve to the second tissue siteincludes anchoring the second portion of the sleeve to a wall of anatrium of the heart of the subject.

There is further provided, in accordance with an application of thepresent invention, a method, including:

percutaneously advancing toward a tissue of a subject an implantincluding a sleeve, while a distal portion of an anchor-delivery channelis disposed within a lumen defined by the sleeve, such that a distalopening of the channel is disposed at a first portion of the sleeve;

anchoring the first portion of the sleeve to the tissue by using ananchor driver to drive a tissue-coupling element of a first anchorthrough the distal opening of the channel, through the sleeve, and intothe tissue;

subsequently, while providing a distally-directed reference force to thefirst anchor via the driver, proximally withdrawing the distal portionof the channel such that the distal opening of the channel is disposedat a second portion of the sleeve;

subsequently, proximally withdrawing the driver through the channel; and

subsequently, anchoring the second portion of the sleeve to the tissueby driving a tissue-coupling element of a second anchor through thedistal opening of the channel, through the sleeve, and into the tissue.

There is further provided, in accordance with an application of thepresent invention, apparatus, for use with a tissue of a subject, theapparatus including:

a percutaneous catheter;

an implant, dimensioned to be advanced into the subject via thecatheter;

an anchor-delivery channel, shaped to define a lumen therethrough, thelumen having a diameter, and the channel being dimensioned to bedisposable within the catheter;

at least one small anchor, including a small-anchor anchor head coupledto a small-anchor tissue-coupling element, and having a centrallongitudinal axis from the small-anchor anchor head to the small-anchortissue-coupling element, a greatest transverse width of the small anchorbeing smaller than the diameter of the lumen of the channel;

at least one large anchor, including a large-anchor anchor head coupledto a large-anchor tissue-coupling element, and having a centrallongitudinal axis from the large-anchor anchor head to the large-anchortissue-coupling element, a greatest transverse width of the large anchorbeing greater than the diameter of the lumen of the channel; and

an anchor driver, including a driver head that is reversibly couplableto the large-anchor anchor head, and a stem that is dimensioned toextend, while the driver head is coupled to the large-anchor anchorhead, from the driver head, through the lumen of the channel, and out ofa proximal end of the channel.

In an application:

the large anchor is disposed at a distal portion of the channel, with atleast the large-anchor tissue-coupling element outside of the lumen ofthe channel,

the driver head is coupled to the large-anchor anchor head,

the stem extends from the driver head, proximally through the lumen ofthe channel, and out of the proximal end of the channel,

the implant is shaped to define a lumen,

the distal portion of the channel and the large-anchor tissue-couplingelement are disposed within the lumen of the implant, and are slidablethrough the catheter with the implant while within the lumen of theimplant.

In an application, the diameter of the lumen of the channel is 2-3 mm.

In an application, the greatest transverse width of the large anchor is3-4 mm.

In an application, the large-anchor tissue-engaging element is shaped todefine a helix having a transverse width of 3-4 mm.

In an application, the large-anchor anchor head has a greatesttransverse width of 2-3 mm.

In an application, the small-anchor tissue-engaging element is shaped todefine a helix having a transverse width of 2-3 mm.

In an application, the greatest transverse width of the large anchor isa greatest transverse width of the large-anchor tissue-coupling element.

In an application, the large-anchor anchor head has a greatesttransverse width that is smaller than the diameter of the lumen of thechannel.

In an application, the large-anchor anchor head has a greatesttransverse width that is greater than the diameter of the lumen of thechannel.

There is additionally provided, in accordance with some applications ofthe present invention, an implant having a body portion, the implantincluding:

a contraction member;

an actuatable adjustment mechanism, coupled to the contraction member,and configured to, when actuated, adjust a dimension of the body portionof the implant by applying tension to the contraction member; and

an adjustment indicator, coupled to the contraction member and directlycoupled to the body portion of the implant, and configured to changeshape according to a degree of tension of the contraction member.

In some applications of the present invention, the implant includes anannuloplasty ring structure.

In some applications of the present invention, the body portion includesa sleeve.

In some applications of the present invention, the adjustment indicatoris directly coupled to an external surface of the body portion of theimplant.

In some applications of the present invention, the adjustment indicatorincludes a radiopaque element.

In some applications of the present invention, the implant includes anannuloplasty structure, and the contraction member is coupled to theannuloplasty structure via the radiopaque element.

In some applications of the present invention:

the radiopaque element includes:

a receptacle; and

a plug shaped so as to fit within the receptacle,

the contraction member is coupled to the radiopaque element by beingcoupled to the plug such that an increase in the degree of tension ofthe contraction member changes the shape of the radiopaque element bypositioning the plug within the receptacle.

In some applications of the present invention, the radiopaque element isdisposed adjacent to the adjustment mechanism.

In some applications of the present invention, the adjustment mechanismis coupled to the contraction member at a first end portion of thecontraction member, and the radiopaque element is coupled to thecontraction member at a second end portion of the contraction member.

In some applications of the present invention, contraction member isthreaded through the radiopaque element.

In some applications of the present invention, the implant includes anannuloplasty structure, and the radiopaque element is coupled to thecontraction member such that an increase in the degree of tension of thecontraction member changes the shape of the radiopaque element bypressing the radiopaque element against the annuloplasty structure.

In some applications of the present invention, the radiopaque elementincludes a band.

In some applications of the present invention, the band has a width of1-3 mm.

In some applications of the present invention:

when tension is not applied to the contraction member, a shape of theband in an unpressed state has an unpressed longitudinal length of 4-6mm measured along a longitudinal axis of the band, and

in response to an increase in the degree of tension of the contractionmember, at least a portion of the band is pressed against the implantassuming a pressed state, and has a pressed longitudinal length of 7-10mm measured along the longitudinal axis of the band.

In some applications of the present invention, the radiopaque elementincludes a tube surrounding a portion of the contraction member.

In some applications of the present invention, the radiopaque element iscoupled to the contraction member such that an increase in the degree oftension of the contraction member changes the shape of the radiopaqueelement by compressing the tube.

In some applications of the present invention, the radiopaque elementincludes a spring.

In some applications of the present invention, the radiopaque element iscoupled to the contraction member such that an increase in the degree oftension of the contraction member changes the shape of the radiopaqueelement by expanding the spring.

In some applications of the present invention, the spring includes avolute spring.

In some applications of the present invention, the spring includes atelescoping spring surrounding a portion of the contraction member.

In some applications of the present invention, the radiopaque element iscoupled to the contraction member such that an increase in the degree oftension of the contraction member changes the shape of the radiopaqueelement by compressing the spring.

In some applications of the present invention:

the radiopaque element is shaped so as to define at least first andsecond arms, and

the contraction member is coupled to the radiopaque element by beingcoupled to each of the first and second arms such that an increase inthe degree of tension of the contraction member changes the shape of theradiopaque element by changing a distance between the first and secondarms.

In some applications of the present invention, in response to theincrease in the degree of tension of the contraction member, the firstand second arms are drawn toward each other.

In some applications of the present invention, the contraction member isthreaded through respective portions of the first and second arms.

There is yet additionally provided, in accordance with some applicationsof the present invention, an implant, the implant including:

an annuloplasty structure having a primary body portion;

a contraction member, extending along at least a contracting portion ofthe annuloplasty structure;

an actuatable adjustment mechanism, coupled to the contraction member,and configured to, when actuated, adjust a length of the annuloplastystructure by applying tension to the contraction member; and

a contraction-member-protecting element, having a first end coupled tothe primary body portion of the annuloplasty structure, and a second endcoupled to the adjustment mechanism,

the contraction member extends from the adjustment mechanism via thecontraction-member-protecting element to the primary body portion of theannuloplasty structure.

In some applications of the present invention, the first end of thecontraction-member-protecting element is connected to the annuloplastystructure at a connection point that is at least 10 mm from any end ofthe annuloplasty structure.

In some applications of the present invention, the annuloplastystructure includes a primary sleeve that includes a tubular lateral wallthat defines a primary lumen through the primary sleeve, thecontraction-member-protecting element includes a secondary sleeve thatdefines a secondary lumen through the secondary sleeve, and a portion ofthe contraction member is disposed within secondary lumen.

In some applications of the present invention, thecontraction-member-protecting element includes a band, and thecontraction member is threaded through the band.

In some applications of the present invention, the band has a width of3-5 mm.

In some applications of the present invention, the band has a band widththat is 10 times greater than a width of the contraction member.

In some applications of the present invention, thecontraction-member-protecting element includes a spring, and thecontraction member is disposed within a lumen of the spring.

In some applications of the present invention:

the first end of the contraction-member-protecting element is connectedto the annuloplasty structure at a connection point,

the annuloplasty structure defines a central longitudinal axis,

the implant has a delivery state in which:

-   -   the implant is percutaneously advanceable through the catheter        to an implant site, and    -   the adjustment mechanism is disposed on the central longitudinal        axis, distal to the annuloplasty structure, and the        contraction-member-protecting element extends from the        connection point, alongside the annuloplasty structure, to the        adjustment mechanism,

the implant has a deployed state in which:

-   -   the adjustment mechanism is disposed laterally to the central        longitudinal axis, and    -   tensioning of the contraction member by the adjustment mechanism        moves the adjustment mechanism closer to the connection point,        and compresses the contraction-member-protecting element.

In some applications of the present invention, thecontraction-member-protecting element has a longitudinal length of 10-15mm prior to the tensioning of the contraction member when measured alongthe central longitudinal axis of the contraction-member-protectingelement.

In some applications of the present invention, the apparatus furtherincludes a plurality of tissue anchors:

the annuloplasty structure has a distal end, and a distal portion thatextends between the connection point and the distal end,

the plurality of tissue anchors includes (i) at least three tissueanchors disposed at the distal portion of the annuloplasty structure,and (ii) at least one tissue anchor disposed in the contracting portionof the annuloplasty structure.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including an implant, the implantincluding:

an annuloplasty structure including a primary sleeve that includes atubular lateral wall that defines a primary lumen through the primarysleeve;

a contraction member, having a first portion extending along at least acontracting portion of the primary sleeve of the annuloplasty structure,the contraction member exiting the primary lumen at an exit point of theprimary lumen;

an actuatable adjustment mechanism, coupled to the contraction member atan end portion of the contraction member, and configured to, whenactuated, adjust a length of the annuloplasty structure by applyingtension to the contraction member; and

a secondary sleeve coupled to the primary sleeve at the exit point ofthe contraction member from the primary lumen, the secondary sleeve:

-   -   defining a secondary lumen through the secondary sleeve, a        second portion of the contraction member is disposed within        secondary lumen and extends to the adjustment mechanism, and    -   coupling the adjustment mechanism to the primary sleeve.

There is yet further provided, in accordance with some applications ofthe present invention, apparatus for use with a subject, the apparatusincluding:

a catheter, transluminally advanceable into the subject; and

an implant advanceable through the catheter, the implant including aflexible sleeve that defines a lumen having a proximal end, a distalend, and a central longitudinal axis therebetween, the implant beingtwisted about the longitudinal axis of the sleeve and beinglongitudinally slidable through the catheter while the sleeve is twistedabout the longitudinal axis of the sleeve.

In some applications of the present invention, an angle of twist betweena proximal end and a distal end of the sleeve that is 170-190 degrees.

In some applications of the present invention, the apparatus furtherincludes a channel longitudinally slidable through the catheter, theflexible sleeve of the implant encases a distal portion of the channelwhile the sleeve is twisted about the axis of the sleeve, and theimplant is longitudinally slidable through the catheter with thechannel, while the sleeve encases the distal portion of the channelwhile the sleeve is twisted about the axis of the sleeve.

In some applications of the present invention, the apparatus furtherincludes:

a contraction member that extends longitudinally along the sleeve; and

an actuatable adjustment mechanism, coupled to the contraction member,and configured to, when actuated, adjust a dimension of the implant byapplying tension to the contraction member.

In some applications of the present invention, the contraction memberhas a first end portion that is coupled to the adjustment mechanism, anda second end portion that is coupled to the sleeve of the implant, whilethe sleeve is twisted about the axis of the sleeve, the adjustmentmechanism is twisted from the second end portion of the contractionmember at an angle of twist between 155 and 175 degrees.

In some applications of the present invention, the apparatus furtherincludes a channel longitudinally slidable through the catheter, theflexible sleeve of the implant encases a distal portion of the channelwhile twisted about the axis of the sleeve, and the implant islongitudinally slidable through the catheter with the channel, while thesleeve encases the distal portion of the channel while twisted about theaxis of the sleeve.

In some applications of the present invention, when the sleeve encasesthe distal portion of the channel while twisted about the axis of thesleeve, the implant is rotated around a central longitudinal axis of thechannel.

In some applications of the present invention, the contraction memberhas a first end portion that is coupled to the adjustment mechanism, anda second end portion that is coupled to a portion of the sleeve of theimplant, and the contraction member defines:

a first longitudinal portion that extends from the adjustment mechanismalong a first longitudinal path,

a second longitudinal portion that extends to the portion of the sleeveof the implant along a second longitudinal path that is offset withrespect to the first longitudinal path, and

an offsetting portion which offsets the first and second longitudinalportions of the contraction member.

In some applications of the present invention, the offsetting portionextends along a stepped path.

In some applications of the present invention, the offsetting portionextends along a helical path.

In some applications of the present invention, the sleeve of the implantis tubular and the first and second longitudinal portions are offset bya distance of 0.3-0.7 radians.

In some applications of the present invention, the first and secondlongitudinal portions are offset by a distance of 0.8-1.2 mm.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus, including an implant, the implantincluding:

an annuloplasty structure having a body portion;

a contraction member, extending along at least a contracting portion ofthe annuloplasty structure; and

an actuatable adjustment mechanism, coupled to the contraction member,and configured to, when actuated, adjust a length of the annuloplastystructure by applying tension to the contraction member,

the contraction member has a first end portion that is coupled to theadjustment mechanism, and a second end portion that is coupled to aportion of the body portion of the implant, the contraction memberdefining:

-   -   a first longitudinal portion that extends from the adjustment        mechanism along a first longitudinal path,    -   a second longitudinal portion that extends to the portion of the        sleeve of the implant along a second longitudinal path that is        offset with respect to the first longitudinal path, and    -   an offsetting portion which offsets the first and second        longitudinal portions of the contraction member.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus for use with a subject, the apparatusincluding:

a flexible sleeve, transluminally advanceable into the subject, andincluding a tubular lateral wall that (i) circumscribes a centrallongitudinal axis of the sleeve, and (ii) defines a lumen having adistal end, a proximal end, and a length therebetween; and

a longitudinal contraction member:

-   -   coupled to the flexible sleeve such that tensioning the        contraction member reduces the length of the lumen, and    -   coupled to the lateral wall such that, in an absence of torsion        of the sleeve around the longitudinal axis, at least part of the        contraction member is disposed helically around the longitudinal        axis.

In some applications of the present invention, the contraction member iswoven through the lateral wall.

In some applications of the present invention, the contraction memberextends along at least a contracting portion of the sleeve.

In some applications of the present invention, the contraction memberextends along at least the contracting portion of the sleeve at an angleof twist between a proximal end and a distal end of the sleeve that is170-190 degrees.

In some applications of the present invention, further including anactuatable adjustment mechanism coupled to the contraction member, andconfigured to, when actuated, adjust a dimension of the sleeve byapplying tension to the contraction member.

In some applications of the present invention, the contraction memberhas a first end portion that is coupled to the adjustment mechanism, anda second end portion that is coupled to the sleeve of the implant, whilethe contraction member is disposed helically about the axis of thesleeve, the adjustment mechanism is twisted from the second end portionof the contraction member at an angle of twist between 140-180 degrees.

There is yet additionally provided, in accordance with some applicationsof the present invention, apparatus for use with a subject, theapparatus including:

a primary body portion, transluminally advanceable into the subject thathas a distal end, a proximal end, and a length therebetween measuredalong a longitudinal axis of the primary body portion; and

a longitudinal contraction member:

-   -   coupled to the primary body portion such that tensioning the        contraction member reduces the length of the primary body        portion, and    -   coupled to the primary body portion such that, in an absence of        torsion of the primary body portion around the longitudinal        axis, at least part of the contraction member is disposed        helically around the longitudinal axis.

There is yet further provided, in accordance with some applications ofthe present invention, apparatus for use with a subject, the apparatusincluding:

an annuloplasty structure having a primary body portion, theannuloplasty structure being transluminally advanceable into thesubject; and

a longitudinal contraction member:

-   -   coupled to the annuloplasty structure such that tensioning the        contraction member reduces a length of the primary body portion        of the annuloplasty structure, and    -   woven a plurality of times through the primary body portion,    -   the primary body portion of the annuloplasty structure defines        first and second holes, a portion of the contraction member        exiting away from the primary body portion through the first        hole and reengaging the primary body portion through the second        hole.

In some applications of the present invention:

the primary body portion includes a sleeve defining a lumentherethrough,

the contraction member is woven in and out of the lumen of the sleeve,and

the sleeve defines first and second holes, a portion of the contractionmember exiting away from the sleeve through the first hole andreentering the lumen of the sleeve through the second hole.

In some applications of the present invention, the second hole isdisposed at a distance of 16-22 mm from an end of the primary bodyportion.

In some applications of the present invention, the primary body portiondefines a contraction-member-free section of the primary body portionthat is between the first and second holes has a degree of friction thatis less than sections of the primary body portion that are adjacent tothe first and second holes and to the contraction-member-free section.

In some applications of the present invention, the apparatus furtherincludes an actuatable adjustment mechanism coupled to the contractionmember, and configured to, when actuated, adjust a dimension of theprimary body portion of the annuloplasty structure by applying tensionto the contraction member.

In some applications of the present invention, the contraction memberhas a first end portion that is coupled to the adjustment mechanism, anda second end portion that is coupled to the primary body portion of theannuloplasty structure.

In some applications of the present invention, the apparatus furtherincludes a contraction-member-protecting element, having a first endcoupled to the primary body portion of the annuloplasty structure, and asecond end coupled to the adjustment mechanism, the contraction memberextends from the adjustment mechanism via thecontraction-member-protecting element to the primary body portion of theannuloplasty structure.

In some applications of the present invention, the first end of thecontraction-member-protecting element is connected to the annuloplastystructure at a connection point that is at least 10 mm from any end ofthe annuloplasty structure.

In some applications of the present invention, the first and secondholes are disposed in a vicinity of the connection point.

There is also provided, in accordance with some applications of thepresent invention, apparatus for use with a subject, the apparatusincluding:

an annuloplasty structure having a primary body portion, theannuloplasty structure being transluminally advanceable into thesubject; and

a longitudinal contraction member coupled to the annuloplasty structuresuch that tensioning the contraction member reduces a length of theprimary body portion of the annuloplasty structure,

the annuloplasty structure defines a first portion having a first degreeof friction between the primary body portion and a first portion of thecontraction member, and

the annuloplasty structure defines a second portion having a seconddegree of friction between the primary body portion and a second portionof the contraction member, the second degree of tension being less thanthe first degree of tension.

In some applications of the present invention:

the first portion of the contraction member is woven a plurality oftimes through the primary body portion in the first portion of theannuloplasty structure, and

the second portion of the annuloplasty structure defines first andsecond holes in the primary body portion of the annuloplasty structure,the second portion of the contraction member exiting away from theprimary body portion through the first hole and reengaging the primarybody portion through the second hole.

There is also provided, in accordance with some applications of thepresent invention, apparatus, including:

a tube having a distal end configured for advancement into a heart of apatient;

an implant movable at least in part through a lumen of the tube, theimplant including:

-   -   an annuloplasty structure having a body portion;    -   a contraction member, extending along at least a contracting        portion of the annuloplasty structure and until 10-15 mm from an        end of the body portion; and    -   an actuatable adjustment mechanism, coupled to the contraction        member, and configured to, when actuated, adjust a length of the        annuloplasty structure by applying tension to the contraction        member,

a portion of the adjustment mechanism is disposed distally to the distalend of the tube while the contraction member is disposed entirely withinthe tube.

In some applications of the present invention, the adjustment mechanismis movable with respect to the primary body portion.

There is also provided, in accordance with some applications of thepresent invention, apparatus, including:

a tube having a distal end configured for advancement into a heart of apatient;

an implant movable at least in part through a lumen of the tube, theimplant including:

-   -   an annuloplasty structure having a body portion;    -   a contraction member, extending along at least a contracting        portion of the annuloplasty structure and until 10-15 mm from an        end of the body portion; and    -   an actuatable adjustment mechanism, coupled to the contraction        member, and configured to, when actuated, adjust a length of the        annuloplasty structure by applying tension to the contraction        member,

a distal-most portion of the contraction member is disposed distally tothe distal end of the tube at a first distance from the distal end ofthe tube and a portion of the adjustment mechanism is disposed distallyto the contraction member at a second distance from the distal end ofthe tube that is greater than the first distance.

There is also provided, in accordance with some applications of thepresent invention, the following inventive concepts:

1. A method, comprising:

advancing a distal end of an anchor driver through a catheter and towarda tissue of a subject, the anchor driver including a shaft, atissue-piercing lance, and a deployment element;

subsequently, piercing the tissue with the lance;

deflecting a distal portion of the shaft with respect to another portionof the shaft immediately proximal to the distal portion, by moving adistal segment of the catheter while at least some of the lance isdisposed within the tissue; and

while (i) the distal portion of the shaft is deflected with respect tothe other portion of the shaft, and (ii) the deployment element islocked to a head of an anchor, driving a tissue-engaging member of theanchor into the tissue using the anchor driver.

2. A method for use with an implant, the method comprising:

using an implant-manipulating handle, coupled to the implant, topercutaneously advance the implant through a catheter toward an implantsite of a subject;

by applying a first force to the implant-manipulating handle, slidingthe implant with respect to the catheter without causing the implant toapply force to tissue at the implant site;

measuring a magnitude of the first force;

subsequently, anchoring the implant to tissue at the implant site;

subsequently, by applying a second force to the implant-manipulatinghandle, causing the implant to apply a third force to tissue at theimplant site via the anchoring of the implant;

measuring a magnitude of the second force; and

determining a magnitude of the third force at least in part responsivelyto a difference between the magnitude of the first force and themagnitude of the second force.

3. The method according to inventive concept 2, sliding the implant byapplying the first force to the implant-manipulating handle comprisessliding the implant proximally with respect to the catheter by applyingthe first force to the implant-manipulating handle.4. The method according to inventive concept 2, wherein:

measuring the magnitude of the first force comprises measuring themagnitude of the first force using a force gauge,

measuring the magnitude of the second force comprises measuring themagnitude of the second force using the force gauge, and

the method further comprises, subsequently to measuring the magnitude ofthe first force and prior to causing the implant to apply the thirdforce, zeroing the force gauge to the magnitude of the first force.

5. The method according to inventive concept 2, wherein:

the anchor-manipulator handle includes a force gauge,

measuring the magnitude of the first force comprises measuring themagnitude of the first force using the force gauge, and

measuring the magnitude of the second force comprises measuring themagnitude of the second force using the force gauge.

6. The method according to any one of inventive concepts 2-5, anchoringthe implant comprises anchoring the implant by driving a tissue anchorinto tissue at the implant site.

7. The method according to inventive concept 6, causing the implant toapply the third force by applying the second force to theimplant-manipulating handle comprises, by applying the second force tothe implant-manipulating handle, causing the implant to apply the thirdforce via the tissue anchor.8. A method for using an adjustment tool with an implant, the methodcomprising:

transluminally implanting the implant in a heart of a subject, such thata guide wire extends from an adjustment device of the implant, theadjustment device including an adjustment mechanism and a lock, theadjustment mechanism configured to change a dimension of the implantupon actuation of the adjustment mechanism, and the lock having (i) alocked state in which the lock inhibits actuation of the adjustmentmechanism, and (ii) an unlocked state in which the adjustment mechanismis actuatable;

subsequently, advancing the adjustment tool along and over the guidewire to the adjustment device;

subsequently, using the tool, actuating the adjustment mechanism whilethe lock is in the unlocked state;

subsequently, unlocking the lock using the tool, and withdrawing thetool along and over the guide wire away from the adjustment device,leaving the lock in the locked state;

while the tool remains withdrawn, and is coupled to the adjustmentdevice only by the guide wire, observing a function of the heart;

subsequently, returning the adjustment tool along and over the guidewire to the adjustment device, and using the tool: unlocking the lock,and actuating the adjustment mechanism; and

subsequently, (i) using the tool: locking the lock, and decoupling theguide wire from the locking device, and (ii) withdrawing the guide wireand the tool from the subject.

9. A method, comprising:

percutaneously advancing toward a tissue of a subject an implantincluding a sleeve that defines a tubular lateral wall and a lumen,while a distal portion of an anchor-delivery channel is disposed withinthe lumen, such that a distal opening of the channel is disposed at afirst portion of the sleeve;

anchoring the first portion of the sleeve to a first tissue site byusing an anchor driver to drive a tissue-coupling element of a firstanchor through the distal opening of the channel, through the lateralwall at the first portion of the sleeve, and into the first tissue site;

pressing a second portion of the sleeve against a second tissue site;and

anchoring the second portion of the sleeve to a second tissue site bydriving a tissue-coupling element of a second anchor from outside thelumen, through opposing sides of the lateral wall at the second portionof the sleeve, and into the second tissue site.

10. The method according to inventive concept 9, pressing the secondportion of the sleeve against the second tissue site comprises pressingthe second portion of the sleeve against the second tissue site suchthat the opposing sides of the lateral wall at the second portion of thesleeve contact each other.11. The method according to inventive concept 9, wherein:

the implant includes an annuloplasty structure that includes the sleeve,

anchoring the first portion of the sleeve to the first tissue sitecomprises anchoring the first portion of the sleeve to an annulus of anatrioventricular valve of a heart of a subject, and

anchoring the second portion of the sleeve to the second tissue sitecomprises anchoring the second portion of the sleeve to a wall of anatrium of the heart of the subject.

12. A method, comprising:

percutaneously advancing toward a tissue of a subject an implantcomprising a sleeve, while a distal portion of an anchor-deliverychannel is disposed within a lumen defined by the sleeve, such that adistal opening of the channel is disposed at a first portion of thesleeve;

anchoring the first portion of the sleeve to the tissue by using ananchor driver to drive a tissue-coupling element of a first anchorthrough the distal opening of the channel, through the sleeve, and intothe tissue;

subsequently, while providing a distally-directed reference force to thefirst anchor via the driver, proximally withdrawing the distal portionof the channel such that the distal opening of the channel is disposedat a second portion of the sleeve;

subsequently, proximally withdrawing the driver through the channel; and

subsequently, anchoring the second portion of the sleeve to the tissueby driving a tissue-coupling element of a second anchor through thedistal opening of the channel, through the sleeve, and into the tissue.

13. A method, comprising:

providing and implant including:

-   -   an annuloplasty structure having a body portion;    -   a contraction member having (1) a first portion extending along        at least a contracting portion of the annuloplasty structure,        and (2) a second portion that extends away from the body portion        of the annuloplasty structure; and    -   an actuatable adjustment mechanism, coupled to the second        portion of the contraction member, the second portion of the        contraction member extending away from the body portion and to        the adjustment mechanism, the adjustment mechanism configured        to, when actuated, adjust a length of the body portion of the        annuloplasty structure by applying tension to the contraction        member; and

delivering the implant to a chamber of a heart of a subject through acatheter in a manner in which the adjustment mechanism is disposeddistally to the body portion of the annuloplasty structure;

deploying a portion of the annuloplasty structure in the chamber suchthat the adjustment mechanism is distanced from the body portion of theannuloplasty structure by a distance of 10-15 mm via the second portionof the contraction member; and

subsequently to the deploying, reducing the distance between theadjustment mechanism and the body portion by actuating the adjustmentmechanism.

14. A method, comprising:

transluminally advancing a catheter into a subject;

providing an implant, the implant including a flexible sleeve thatdefines a lumen having a proximal end, a distal end, and a centrallongitudinal axis therebetween; and

advancing the implant through the catheter, while the flexible sleeveencases the distal portion of the channel while twisted about the axisof the sleeve.

15. The method according to inventive concept 14, providing the implantfurther comprises providing a channel, the flexible sleeve encases adistal portion of the channel while twisted about the axis.

16. The method according to inventive concept 14, an angle of twistbetween the proximal end and the distal end is 170-190 degrees.

17. The method according to inventive concept 14, further comprising,subsequently to the advancing, progressively releasing successiveportions of the sleeve off of the channel, and anchoring the successiveportions to tissue of the subject, such that an angle of twist of thesleeve becomes reduced.18. The method according to inventive concept 14, the providing theimplant comprises providing the implant including:

a contraction member that extends longitudinally along the sleeve; and

an actuatable adjustment mechanism, coupled to the contraction member,and configured to, when actuated, adjust a dimension of the implant byapplying tension to the contraction member.

19. The method according to inventive concept 18, the contraction memberhas a first end portion that is coupled to the adjustment mechanism, anda second end portion that is coupled to the sleeve of the implant, whilethe sleeve is twisted about the axis of the sleeve, the adjustmentmechanism is twisted from the second end portion of the contractionmember at an angle of twist between 170-190 degrees.20. The method according to inventive concept 18, providing the implantfurther comprises providing a channel, the flexible sleeve encases adistal portion of the channel while twisted about the axis of thesleeve.21. The method according to inventive concept 20, further comprising,prior to the advancing of the implant, when the sleeve encases thedistal portion of the channel while twisted about the axis of thesleeve, rotating the implant in a first rotational direction around acentral longitudinal axis of the channel.22. A method for use with a heart of a subject, the method comprising:

using an implantation assembly, advancing, to a site in the heart, animplant that includes an implant-adjustment mechanism to which iscoupled a flexible wire of the implantation assembly, the implantationassembly further including an adjustment tool that is slidable along andover the flexible wire, and is reversibly-engageable with theimplant-adjustment mechanism;

securing the implant at the site in the heart, such that the flexiblewire extends from the implant-adjustment mechanism out of the heart;

subsequently, actuating the implant-adjustment mechanism using theadjustment tool while the adjustment tool is disposed over the flexiblewire, and is engaged with the implant-adjustment mechanism;

subsequently, disengaging and withdrawing the adjustment tool from theimplant-adjustment mechanism by moving the adjustment tool along andover the flexible wire while the flexible wire remains coupled to theimplant-adjustment mechanism;

subsequently, while (i) the adjustment tool remains withdrawn from theimplant-adjustment mechanism, and (ii) the flexible wire remains coupledto the implant-adjustment mechanism, detecting a parameter of the heart;

subsequently, reengaging the adjustment tool with the implant-adjustmentmechanism by moving the adjustment tool along and over the flexible wiretoward the implant-adjustment mechanism while the flexible wire remainscoupled to the implant-adjustment mechanism; and

subsequently, re-actuating the implant-adjustment mechanism using theadjustment tool while the adjustment tool is disposed over the flexiblewire, and is engaged with the implant-adjustment mechanism.

23. The method according to inventive concept 22, detecting theparameter of the heart comprises detecting the parameter of the heartwhile the flexible wire is the only part of the implantation assemblythat is in contact with the implant.

24. The method according to inventive concept 22, further comprising:

locking the implant-adjustment mechanism after actuating theimplant-adjustment mechanism, and before withdrawing the adjustmenttool; and

unlocking the adjustment mechanism after moving the adjustment toolalong and over the flexible wire toward the implant-adjustmentmechanism, and before re-actuating the implant-adjustment mechanism.

25. The method according to inventive concept 24, locking theimplant-adjustment mechanism comprises locking the implant-adjustmentmechanism using the implantation assembly, and unlocking theimplant-adjustment mechanism comprises unlocking the implant-adjustmentmechanism using the implantation assembly.26. The method according to inventive concept 22, further comprising,after re-actuating the implant-adjustment mechanism, decoupling theflexible wire from the adjustment mechanism.27. The method according to inventive concept 26, decoupling theflexible wire from the implant-adjustment mechanism comprises using theimplantation assembly to decouple the flexible wire from theimplant-adjustment mechanism.28. The method according to inventive concept 26, further comprisingre-locking the implant-adjustment mechanism before decoupling theflexible wire from the adjustment mechanism.29. The method according to inventive concept 22, detecting theparameter of the heart comprises detecting the parameter of the heartusing echocardiography.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an annuloplasty ring structure,comprising a sleeve and an adjustment mechanism, in accordance with someapplications of the invention;

FIG. 2 is a schematic illustration of a multi-component tubular systemfor delivering and anchoring an implant and for controlling a relativespatial orientation of components of the catheter system, in accordancewith some applications of the present invention;

FIGS. 3A-G are schematic illustrations of steps in the implantation ofan annuloplasty ring structure to repair a mitral valve, in accordancewith some applications of the invention;

FIGS. 4A and 4B are schematic illustrations that show steps between thestate shown in FIG. 3C and the state shown in FIG. 3D, in accordancewith respective applications of the invention;

FIGS. 5A-B are schematic illustrations of techniques for use with anexcess portion of sleeve, in accordance with some applications of theinvention;

FIGS. 6A-B and 7A-B are schematic illustrations of steering ofcatheters, in accordance with respective applications of the invention;

FIGS. 8A-B, 9, 10A-C, 11, and 12A-B are schematic illustrations oftissue anchors, and the use of the tissue anchors for implantation of animplant, in accordance with some applications of the invention;

FIGS. 13A-D and 14A-F are schematic illustrations of a system,comprising a tissue anchor, an anchor driver, and a lance, andtechniques for use with the system, in accordance with some applicationsof the invention;

FIGS. 15A-B are schematic illustrations of implants that comprise acontracting wire, in accordance with some applications of the invention;

FIGS. 16A-B, 17A-C and 18A-K are schematic illustrations of a system fordocking with and adjusting an adjustment mechanism of apercutaneously-implantable implant, and techniques for use therewith, inaccordance with some applications of the invention;

FIGS. 19A-F are schematic illustrations of a force gauge, and techniquesfor use thereof, in accordance with some applications of the invention;

FIG. 20 is a schematic illustration of an annuloplasty structure in adelivery and implanted state, in accordance with some applications ofthe invention;

FIG. 21 is a schematic illustration of an annuloplasty structure in adelivery and implanted state showing a contraction member having anoffsetting region, in accordance with some applications of theinvention;

FIGS. 22A-C are schematic illustrations of an annuloplasty structure inrespective twisted and/or rotated states of delivery, in accordance withsome applications of the invention;

FIGS. 23A-B are schematic illustrations of an annuloplasty structurecomprising a primary and secondary sleeve, in accordance with someapplications of the invention;

FIGS. 24A-B are schematic illustrations of the annuloplasty structure ofFIGS. 23A-B comprising a volute spring, in accordance with someapplications of the invention;

FIGS. 25A-B are schematic illustrations of an annuloplasty structurecomprising a contraction-member protecting band, in accordance with someapplications of the invention;

FIGS. 26A-B, 27A-B, 28A-B, and 29A-B are schematic illustrations of anannuloplasty structure comprising respective adjustment indicators, inaccordance with respective applications of the invention;

FIG. 30 is a schematic illustration of an annuloplasty structure in anda contraction member disposed helically with respect to the sleeve ofthe annuloplasty structure, in accordance with some applications of theinvention; and

FIGS. 31A-C are schematic illustrations of an annuloplasty structure inbeing shaped so as to define holes, in accordance with some applicationsof the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa multi-component tubular system 10 providing one or morerotationally-controlled steering catheters configured for delivering animplant to a heart of a subject, in accordance with some applications ofthe present invention.

FIG. 1 shows a distal portion of an implant that comprises anannuloplasty ring structure 222 (i.e., an implant, e.g., an annuloplastyband) comprising a flexible sleeve 26 (shown in the exploded view ofFIG. 2). Sleeve 26 typically comprises a braided fabric mesh, e.g.,comprising polyethylene terephthalate (such as Dacron™). Sleeve 26 istypically configured to be placed only partially around a cardiac valveannulus (i.e., to assume a C-shape), and, once anchored in place, to becontracted so as to circumferentially tighten the valve annulus.Alternatively, the ring structure is configured to be placed entirelyaround the valve annulus.

Sleeve 26 has (a) a tubular lateral wall 253 that (i) circumscribes acentral longitudinal axis of the sleeve, and (ii) defines the lumen ofthe sleeve, and (a) at least one end wall 251 (e.g., a distal end wall)having a surface that is substantially transverse to a lateral surfaceof tubular wall 253. Typically, end wall 251 defines an end wall ofannuloplasty ring structure 222.

In order to tighten the annulus, annuloplasty ring structure 222comprises a flexible elongated contraction member 226 that extends alongsleeve 26. Elongated contraction member 226 comprises a wire, a ribbon,a rope, or a band, which typically comprises a flexible and/orsuperelastic material, e.g., nitinol, polyester, stainless steel, orcobalt chrome. For some applications, the wire comprises a radiopaquematerial. For some applications, contraction member 226 comprises abraided polyester suture (e.g., Ticron). For some applications,contraction member 226 is coated with polytetrafluoroethylene (PTFE).For some applications, contraction member 226 comprises a plurality ofwires that are intertwined to form a rope structure.

Annuloplasty ring structure 222 further comprises an adjustmentmechanism 40, which facilitates contracting and expanding ofannuloplasty ring structure 222 so as to facilitate adjusting of aperimeter of the annulus and leaflets of the cardiac valve. Adjustmentmechanism 40 is described in more detail hereinbelow. Adjustmentmechanism 40 comprises a rotatable structure (e.g., a spool, asdescribed hereinbelow) that is disposed within a housing 44. For someapplications of the present invention, adjustment mechanism 40 comprisesthe housing 44. Adjustment mechanism 40 may be surrounded by a braidedmesh, coupled (e.g., by being sutured or otherwise coupled) to thebraided mesh of sleeve 26. For some applications, adjustment mechanism40 is coupled to an outer, lateral surface of sleeve 26.

Reference is now made to FIG. 2, which shows the concentric relationshipbetween components of tubular system 10 (in an exploded view on the leftside of FIG. 2). System 10 comprises an implant-delivery tool.Typically, system 10 comprises a first, outer catheter 12 comprising asheath configured for transluminal advancement through vasculature of asubject. For some applications of the present invention, outer catheter12 comprises a sheath configured for advancement through a femoralartery toward an interatrial septum of a heart of a subject. A distalend portion 112 of outer catheter 12 is configured to pass through thetransatrial septum of the subject, and to be oriented in a desiredspatial orientation within the left atrium. System 10 comprises a secondcatheter, or guide catheter 14, comprising a distal end portion 114 thatis configured to pass through catheter 12 (i.e., a primary lumenthereof), to become disposed outside of a distal end 102 of the outercatheter, and to be oriented in a desired spatial orientation within theleft atrium.

Distal end portion 112 of outer catheter 12 is steerable. That is,distal end portion 112 is deflectable with respect to an immediatelymore proximal portion of catheter 12 (e.g., by using extracorporealelements of system 10). Distal end portion 112 comprises a pull ring 11that is coupled to two or more pull wires 29 a and 29 b, that aredisposed within respective secondary lumens within a lateral wall ofcatheter 12 (as shown in section A-A of FIG. 2). As shown in theexploded view, guide catheter 14 is configured to be concentricallydisposed within the lumen of catheter 12. Distal end portion 114 ofinner catheter 14 is steerable. That is, distal end portion 114 isdeflectable with respect to an immediately more proximal portion ofcatheter 14 (e.g., by using extracorporeal elements of system 10).Distal end portion 114 comprises a pull ring 13 that is coupled to twoor more pull wires 31 a and 31 b, that are disposed within respectivesecondary lumens within a wall of catheter 14 (as shown in sections A-Aand B-B).

Guide catheter 14 is steerable to a desired spatial orientation in orderto facilitate advancing and implantation of an implant in a body cavityof the subject.

For applications in which system 10 is used to deliver an implant to themitral valve of the subject, typically, outer catheter 12 is configuredfor initial advancement through vasculature of the subject until adistal end 102 of catheter 12 is positioned in the left atrium. Thedistal steerable end portion of catheter 12 is then steered such thatdistal end 102 of catheter 12 is positioned in a desired spatialorientation within the left atrium. The steering procedure is typicallyperformed with the aid of imaging, such as fluoroscopy, transesophagealecho, and/or echocardiography. Following the steering of the distal endportion of catheter 12, guide catheter 14 (which houses annuloplastyring structure 222) is advanced through catheter 12 in order tofacilitate delivery and implantation of structure 222 along the annulusof the mitral valve. During the delivery, at least a portion ofsteerable distal end portion 114 is exposed from distal end 102 ofcatheter 12 and is thus free for steering toward the annulus of themitral valve, as is described hereinbelow.

During delivery of sleeve 26 to the annulus of the cardiac valve, sleeve26 and mechanism 40 are disposed within a lumen of catheter 14 and aretypically aligned longitudinally with a longitudinal axis of catheter14. Mechanism 40 is coupled to sleeve 26 in a manner that allowsmechanism 40 to move (e.g., to translate) from a state in which it is inline with the longitudinal axis of catheter 14 (FIG. 2) to a state inwhich it is disposed alongside sleeve 26 (FIG. 1). For example,adjustment mechanism 40 may be coupled to sleeve 26 via one or moreconnectors 27, such as sutures, which provide flexible and/orarticulated coupling. For some applications, the positioning ofadjustment mechanism 40 alongside a portion of sleeve 26 exposes adriving interface of the rotational structure (e.g., a driving interface476, FIG. 16A), providing access to the interface for an adjustment toolthat is subsequently guided toward adjustment mechanism 40 via a guidemember 86.

Reference is again made to FIG. 1. A flexible, longitudinal guide member86 (e.g., a wire) is coupled to a portion of adjustment mechanism 40(e.g., a portion of the rotatable structure, as described hereinbelow).Guide member 86 has a thickness of 0.35-0.45 mm, e.g., 0.4 mm. Guidemember 86 is configured to facilitate guiding of an adjustment tool viaguide member 86 and toward the rotatable structure of adjustmentmechanism 40. Typically, the adjustment tool is configured to engage therotatable structure of adjustment mechanism 40 following implantation ofsleeve 26 along the annulus of the cardiac valve. Guide member 86extends from adjustment mechanism 40, alongside a portion of distal endportion 114 of guide catheter 14, and into a secondary lumen in the wallof guide catheter 14 via an opening 15 in guide catheter 14. Guidemember 86 extends through the secondary lumen of guide catheter 14 (asshown in sections A-A and B-B in FIG. 2) and has a proximal end that isaccessible from outside the body of the subject. The secondary lumen inthe wall of guide catheter 14 facilitates passage of guide member 86through system 10 without interfering with the otherconcentrically-disposed elongate tubular members that passconcentrically through the lumen of guide catheter 14.

Reference is again made to FIG. 2. In addition, system 10 comprises aplurality of anchors 32, typically between about 5 and about 20 anchors,such as about 10 or about 16 anchors. Each anchor 32 comprises atissue-coupling element 60 (e.g., a helical tissue-coupling element),and a tool-engaging head 62 (e.g., a non-helically-shaped portion),fixed to one end of the tissue-coupling element. Only one anchor 32 isshown in FIG. 2 as being reversibly coupled to a deployment element 38of an anchor driver 36 of an anchor deployment manipulator 61. However,each of anchors 32 is reversibly couplable to a deployment element 38 ofone or more anchor drivers 36. When sleeve 26 is disposed along theannulus of the cardiac valve, deployment manipulator 61 is configured toadvance within a lumen of sleeve 26 and deploy each anchor 32 fromwithin sleeve 26 through a wall of sleeve 26 and into cardiac tissue,thereby anchoring sleeve 26 around a portion of the valve annulus. Theinsertion of the anchors into the sleeve and deployment of the anchorsinto cardiac tissue is described in detail hereinbelow.

Typically, but not necessarily, anchors 32 comprise a biocompatiblematerial such as stainless steel 316 LVM. For some applications, anchors32 comprise nitinol. For some applications, anchors 32 are coated fullyor partially with a non-conductive material.

Deployment manipulator 61 comprises anchor driver 36 and deploymentelement 38. For some applications, deployment manipulator 61 compriseschannel 18.

As shown in the exploded view of FIG. 2, sleeve 26 is disposed within alumen of guide catheter 14. Forces are applicable to a proximal end ofsleeve 26 via a reference-force tube 19, a distal end of which iscoupled to the proximal end of the sleeve. As shown, animplant-decoupling channel 18 is advanceable within a lumen ofreference-force tube 19 and within a lumen of sleeve 26. As shown in theenlarged image of FIG. 1, a distal end 17 of implant-decoupling channel18 is placeable in contact with an inner wall of sleeve 26, e.g., at adistal end thereof. The distal end portion of channel 18 may comprise aradiopaque marker 1018. As shown, tube 19 and sleeve 26 arelongitudinally and coaxially disposed with respect to each other.

For some applications, channel 18 is steerable.

Typically, manipulator 61 advances within channel 18. For someapplications, system 10 comprises a plurality of anchor drivers 36 ofmanipulator 61, each driver 36 being coupled to a respective anchor 32.Each driver 36 is advanced within channel 18 in order to advance andimplant anchor 32 in tissue. Following implantation of anchor 32, anchor32 is decoupled from driver 36, as described herein, and driver 36 isremoved from within channel 18. A subsequent anchor 32 is then advancedwithin channel 18 while coupled to a driver 36 (e.g., a new driver).

As will be described hereinbelow, a first one of anchors 32 isconfigured to be deployed through end wall 251 of sleeve 26 into cardiactissue, when sleeve 26 is positioned along the annulus of the valve.Following the deployment of the first tissue anchor, a distal portion ofsleeve 26 is slid distally off a portion of implant-decoupling channel18. In order to decouple sleeve 26 distally from a portion of outersurface of channel 18, (1) a proximal force is applied to channel 18,while (2) reference-force tube 19 is maintained in place in a manner inwhich a distal end of tube 19 provides a reference force to sleeve 26,thereby facilitating freeing of a successive portion of sleeve 26 fromaround channel 18. Channel 18 is then positioned at a successivelocation within the lumen of sleeve 26 while tube 19 and/or catheter 14is steered toward a successive location along the annulus of the valve(as will be described hereinbelow). Consequently, the successive portionof sleeve 26 provides a free lumen for advancement of a successiveanchor 32 and deployment of the anchor through the wall of the sleeve atthe successive portion thereof. Such freeing of the successive portionof sleeve 26 creates a distance between successive anchors deployed fromwithin the lumen of sleeve 26.

For some applications, sleeve 26 comprises a plurality of radiopaquemarkers 25, which are positioned along the sleeve at respectivelongitudinal sites. The markers may provide an indication in aradiographic image (such as a fluoroscopy image) of how much of thesleeve has been deployed at any given point during an implantationprocedure, in order to enable setting a desired distance between anchors32 along the sleeve. For some applications, the markers comprise aradiopaque ink.

Typically, at least some (e.g., at least three, such as all) of thelongitudinal sites are longitudinally spaced at a constant interval.Typically, the longitudinal distance between the distal edges ofadjacent/consecutive markers, and/or the distance between the proximaledges of adjacent markers, is set equal to the desired distance betweenadjacent anchors. For example, the markers may comprise first, second,and third markers, which first and second markers are adjacent, andwhich second and third markers are adjacent, and the distance betweenthe proximal and/or distal edges of the first and second markers equalthe corresponding distance between the proximal and/or distal edges ofthe second and third markers. For example, the distance may be between 3and 15 mm, such as 6 mm, and the longitudinal length of each marker maybe between 0.1 and 14 mm, such as 2 mm. (If, for example, the distancewere 6 mm and the length were 2 mm, the longitudinal gaps betweenadjacent markers would have lengths of 4 mm.)

Each anchor 32 is coupled to deployment element 38 of an anchor driver36. Anchor driver 36 typically comprises an elongate and flexible shaft(which is typically tubular) having at least a flexible distal endportion. The elongate shaft of driver 36 extends within a lumen ofchannel 18, through system 10 toward a proximal end of a proximal handleportion 101 of system 10. The tube of anchor driver 36 provides a lumenfor slidable advancement therethrough of an elongate rod 130. Rod 130facilitates the locking and unlocking of anchor 32 to deployment element38. As shown in Section E-E of FIG. 2, a proximal end of rod 130 iscoupled to a component of an anchor-release mechanism 28 at a proximalend of system 10. Mechanism 28 comprises a housing 135 and afinger-engager 131 that is coupled to the proximal end of rod 130.Finger-engager 131 is coupled to a housing 135 via a spring 133 (sectionE-E of FIG. 2). A proximal end of the tube of anchor driver 36 iscoupled to housing 135. The physician releases anchor 32 from deploymentelement 38 when finger-engager 131 is pulled proximally, thereby pullingrod 130 proximally.

Proximal handle portion 101 is supported by a stand having support legs91 and a handle-sliding track 90. Handle portion 101 comprises anouter-catheter handle 22, a guide-catheter handle 24, animplant-manipulating handle 126, and anchor-release mechanism 28. Handle22 is coupled to a proximal end of outer catheter 12. Handle 24 iscoupled to a proximal portion of guide catheter 14. Handle 126 iscoupled to a proximal portion of reference-force tube 19, and linearmovement of handle 126 with respect to handle 24 moves reference-forcetube 19 (and thereby typically structure 222) through catheter 14. Asdescribed hereinabove, housing 135 of anchor-release mechanism 28 iscoupled to a proximal portion of the tube of anchor driver 36. Therelative positioning of each of the concentrically-disposed componentsof system 10 is shown in the exploded view and sections A-A, B-B, C-C,and D-D of FIG. 2.

The stand supporting proximal handle portion 101 may be moved distallyand proximally to control a position of the entire multi-componentsystem 10, particularly so as to adjust a distance of distal end 102 ofcatheter 12 from the interatrial septum. Handle 22 comprises a steeringknob 210 that is coupled to steering wires 29 a and 29 b disposed withinrespective secondary lumens in the wall of outer catheter 12. Rotationof knob 210 adjusts a degree of tension of wires 29 a and 29 b which, inturn, apply a force to pull ring 11 at the distal end portion of outercatheter 12. Such force steers the distal end portion of catheter 12within the atrium of the heart of the subject in a manner in which thedistal end portion of catheter 12 is steered in a first steering planethat is typically parallel with the plane of the annulus of the valve(e.g., in a direction from the interatrial septum toward surroundingwalls of the atrium). For some applications of the present invention,the distal end portion of catheter 12 may be pre-shaped so as to pointdownward toward the valve. For other applications, the distal endportion of catheter 12 may be pulled to assume an orientation in whichthe distal end portion points downward toward the valve. For yet otherapplications of the present invention, the distal end portion ofcatheter 12 is not made to point downward toward the valve.

Handle 24 is coupled to track 90 via a first mount 92. Mount 92 isslidable proximally and distally along track 90 in order to control anaxial position of guide catheter 14 with respect to outer catheter 12.Mount 92 is slidable via a control knob 216. For example, control knob216 of mount 92 controls the proximal and distal axial movement of thedistal steerable portion of guide catheter 14 with respect to distal end102 of outer catheter 12. Handle 24 comprises a steering knob 214 thatis coupled to steering wires 31 a and 31 b disposed within respectivesecondary lumens in the wall of guide catheter 14. Rotation of knob 214adjusts a degree of tension of wires 31 a and 31 b which, in turn, applya force to pull ring 13 at the distal end portion of guide catheter 14.Such force steers the distal end portion of catheter 14 in a secondsteering plane within the atrium of the heart of the subject, typicallydownward and toward the annulus of the cardiac valve. Typically, asdescribed hereinbelow, the distal end portion of guide catheter 14 issteered in the second plane that is substantially perpendicular withrespect to the first plane in which the distal end portion of outercatheter 12 is steered.

The combined steering of the respective distal end portions of catheters12 and 14 directs sleeve 26 down toward the annulus (e.g., via thesteering of the distal end portion of catheter 14) and along theperimeter of annulus (e.g., from the posterior section of the valve tothe anterior section of the valve, and vice versa), via the steering ofthe distal end portion of catheter 12.

For some applications, handle 22 may be tilted by the operatingphysician, in order to further adjust a position of the distal end ofcatheter 12.

Handle 126 is slidably coupled to track 90 via a second mount 93. Mount93 is slidable proximally and distally along track 90, in order tocontrol an axial position of reference-force tube 19 and at least aproximal portion of sleeve 26 with respect to guide catheter 14. Forsome applications, mount 93 comprises a control knob 95. For some suchapplications, control knob reversibly locks mount 93 to track 90,thereby reversibly inhibiting sliding of the mount along the track.Alternatively or additionally, turning of control knob 95 may causesliding of mount 93 along track 90 (e.g., acting like a rack andpinion). For some applications, friction between (i) reference-forcetube 19 and (ii) catheter 14 and/or handle 24 reduces a likelihood ofinadvertent sliding of tube 19 through catheter 14, and thereby obviatesthe need for locking of mount 93 to track 90. Taken together with thesteering of the distal end portion of guide catheter 14, such movementof tube 19 and at least the proximal portion sleeve 26 moves theproximal portion of sleeve 26 toward a desired portion of tissue of theannulus of the valve during deployment of anchors 32 from within thelumen of sleeve 26, as is described hereinbelow.

As is described hereinabove, in order to decouple sleeve 26 from aportion of an outer surface of channel 18, (1) channel 18 is pulledproximally, while (2) reference-force tube 19 is maintained in place. Aproximal end of channel 18 is coupled to a knob 94 which adjusts anaxial position of channel 18 proximally and distally with respect toreference-force tube 19 and sleeve 26.

Typically, handle portion 101 comprises a release-decision-facilitationmember 127, such as a latch or button, that automatically engages when agiven length of sleeve 26 has advanced off channel 18 (e.g., whenchannel 18 is at a given position with respect to tube 19); typicallyjust before sleeve 26 becomes completely decoupled from channel 18.Engagement of member 127 inhibits proximal movement of channel 18 withrespect to tube 19, thereby reducing a likelihood of (e.g., preventing)inadvertent release of sleeve 26. In order to release sleeve 26 (e.g.,to decouple channel 18 from the sleeve), the operating physician mustdisengage member 127, such as by pushing the button, before continuingto withdraw channel 18 proximally. Typically, when engaged, member 127also inhibits distal movement of channel 18 with respect to tube 19.

Handle portion 101 (comprising handles 22, 24, and 126 andanchor-release mechanism 28) has a length L1 of between 65 and 85 cm,e.g., 76 cm. Typically, as shown, a majority of the body portion ofouter-catheter handle 22 is disposed at a non-zero angle with respect toa longitudinal axis 7 of the multiple components of system 10. Thesteering mechanism provided by handle 22 in order to steer the distalend portion of catheter 12 is disposed within the portion of handle 22that is disposed at the non-zero angle with respect to axis 7. Handle 22comprises an in-line tubular portion which is longitudinally disposedin-line along axis 7 and coaxially with respect to handles 24 and 126and release mechanism 28. The in-line tubular portion is shaped so as todefine a lumen for inserting guide catheter 14 therethrough andsubsequently into the lumen of outer catheter 12. The in-line tubularportion has a length L24 of between 7 and 11 cm, e.g., 7 cm. Suchspatial orientation of the majority of handle 22 at an angle withrespect to axis 7 reduces an overall functional length of handle portion101.

Typically, but not necessarily, a guidewire 2244 extends alongsidesleeve 26 to facilitate positioning of sleeve 26 along the annulus.

Reference is made to FIGS. 3A-G, and 4A-B, which are schematicillustrations of steps in the implantation of an annuloplasty ringstructure to repair a mitral valve, in accordance with some applicationsof the invention. This procedure is one exemplary procedure that can beperformed using system 10.

Anchor deployment manipulator 61 is advanced into a lumen of sleeve 26,and, from within the lumen, deploys the anchors through a wall of thesleeve and into cardiac tissue, thereby anchoring the sleeve around aportion of the valve annulus. For some application, annuloplasty ringstructure 222 is implemented using techniques described in U.S.application Ser. No. 12/437,103, filed May 7, 2009 which published as US2010/0286767, and/or U.S. application Ser. No. 12/689,635, filed Jan.19, 2010 which published as US 2010/0280604, both of which are assignedto the assignee of the present application and are incorporated hereinby reference. As described hereinabove, annuloplasty ring structure 222comprises adjustment mechanism 40. The adjustment mechanism comprises arotatable structure, such as a spool, arranged such that rotation of therotatable structure contracts the implant structure. The implant furthercomprises a longitudinal member, such as a wire, which is coupled to theadjustment mechanism. An adjustment tool is provided for rotating therotatable structure. The tool is configured to be guided along (e.g.,over, alongside, or through) the longitudinal member, to engage therotatable structure, and to rotate the rotatable structure in responseto a rotational force applied to the tool.

The procedure typically begins by advancing a semi-rigid guidewire intoa right atrium 220 of the subject. The procedure is typically performedwith the aid of imaging, such as fluoroscopy, transesophageal echo,and/or echocardiography.

The guidewire provides a guide for the subsequent advancement of outercatheter 12 therealong and into the right atrium. Once a distal portionof catheter 12 has entered the right atrium, the guidewire is retractedfrom the subject's body. Catheter 12 typically comprises a 14-24 Fsheath, although the size may be selected as appropriate for a givensubject. Catheter 12 is advanced through vasculature into the rightatrium using a suitable point of origin typically determined for a givensubject. For example:

catheter 12 may be introduced into the femoral vein of the subject,through an inferior vena cava 223, into right atrium 220, and into aleft atrium 224 transseptally, typically through the fossa ovalis;

catheter 12 may be introduced into the basilic vein, through thesubclavian vein to the superior vena cava, into right atrium 220, andinto left atrium 224 transseptally, typically through the fossa ovalis;or

catheter 12 may be introduced into the external jugular vein, throughthe subclavian vein to the superior vena cava, into right atrium 220,and into left atrium 224 transseptally, typically through the fossaovalis.

For some applications of the present invention, catheter 12 is advancedthrough inferior vena cava 223 of the subject (as shown) and into rightatrium 220 using a suitable point of origin typically determined for agiven subject.

Catheter 12 is advanced distally until the sheath reaches theinteratrial septum, and the guidewire is withdrawn.

A resilient needle and a dilator are advanced through catheter 12 andinto the heart. In order to advance catheter 12 transseptally into leftatrium 224, the dilator is advanced to the septum, and the needle ispushed from within the dilator and is allowed to puncture the septum tocreate an opening that facilitates passage of the dilator andsubsequently catheter 12 therethrough and into left atrium 224. Thedilator is passed through the hole in the septum created by the needle.Typically, the dilator is shaped to define a hollow shaft for passagealong the needle, and the hollow shaft is shaped to define a tapereddistal end. This tapered distal end is first advanced through the holecreated by the needle. The hole is enlarged when the graduallyincreasing diameter of the distal end of the dilator is pushed throughthe hole in the septum. A distal-most end 102 of catheter 12 is taperedso as to facilitate passage of at least part of distal portion 112 ofcatheter 12 through the opening in the septum.

The advancement of catheter 12 through the septum and into the leftatrium is followed by the extraction of the dilator and the needle fromwithin catheter 12. Once distal portion 112 of catheter 12 is disposedwithin atrium 224, portion 112 is steered (i.e., deflected) in a firststeering plane, typically parallel to a plane of the annulus of mitralvalve 230. The steering of the distal portion of catheter 12 isperformed via steering knob 210 of handle 22 in handle portion 101 (inFIG. 2).

As shown in FIG. 3A, catheter 14, containing annuloplasty ring structure222 (with a distal portion of channel 18 disposed within sleeve 26thereof), is advanced through catheter 12 into left atrium 224. For someapplications, soon before implantation (e.g., within the operatingtheater or in an adjacent room) the distal portion of channel 18 isloaded into sleeve 26, and structure 222 is loaded into catheter 14.Distal end portion 114 of catheter 14 extends beyond distal end 102 ofcatheter 12. Distal end portion 114 is then steered (i.e., deflected) ina second steering plane, typically perpendicular with respect to thesteering plane of catheter 12, and further typically toward the annulusof valve 230. The steering of the distal portion of catheter 14 isperformed via steering knob 214 of handle 24 in handle portion 101 (inFIG. 2).

FIG. 3A shows annuloplasty ring structure 222, comprising sleeve 26 andadjustment mechanism 40, having been advanced, via catheter 14, to amitral valve 230. As shown in FIG. 3A, and as described hereinabove,during advancement of structure 222, adjustment mechanism 40 is disposeddistal to (i.e., in front of) sleeve 26. In this way, adjustmentmechanism 40 is disposed on the longitudinal axis of sleeve 26 (e.g.,collinearly with the sleeve), so as to advantageously maintain a smallcross-sectional diameter of the implant for transluminal delivery. Aproximal end of connector 27 is disposed proximally to mechanism 40(e.g., by being fixed to a portion of sleeve 26 proximal to mechanism 40or by being accessible outside the body of the subject). A distal end ofconnector 27 is coupled (e.g., by being fixedly coupled by a knot orother mechanical coupling) to mechanism 40. Guide member 86, describedhereinabove, typically extends distally from catheter 14, between endwall 251 of sleeve 26 and adjustment mechanism 40, and there is coupledto the adjustment mechanism. For some applications it is advantageous to(1) advance the structure to the mitral valve while mechanism 40 isdisposed on the longitudinal axis of sleeve 26 (e.g., collinearly withthe sleeve), so as to maintain a small cross-sectional diameter of thestructure for transluminal delivery; and (2) to subsequently movemechanism 40 away from the longitudinal axis, e.g., so as to allow endwall 251 of the sleeve to be placed against the annulus, and/or so as toallow an anchor to be driven through the end wall of the sleeve.Connectors 27 facilitate this technique by making mechanism 40 flexiblyand/or articulatably coupled to sleeve 26. For some applications,connectors 27 are tensioned or relaxed to move mechanism 40 with respectto sleeve 26 to reposition mechanism 40. For some applications, guidemember 86 is tensioned or relaxed in order to reposition mechanism 40.

Subsequent to exposure of at least adjustment mechanism 40 (andtypically at least end wall 251 of sleeve 26) from catheter 14, theadjustment mechanism is moved away from end wall 251. Typically, this isachieved by guide member 86 being moved proximally such that mechanism40 moves (e.g., translates, deflects, and/or rotates) away from thelongitudinal axis of the sleeve, typically to become disposed laterallyfrom sleeve 26. FIG. 3B shows mechanism 40 having translated to such aposition. The movement of mechanism 40 away from end wall 251 of sleeve26 advantageously allows end wall 251 of sleeve 26 to be placed againstan atrial surface of an annulus 240, and a first one of anchors 32 to bedriven through end wall 251 of the sleeve and into the annulus (FIG.3C).

As shown in FIG. 3C, end wall 251 of sleeve 26 is positioned in avicinity of a left fibrous trigone 242 of an annulus 240 of mitral valve230. (It is noted that for clarity of illustration, distal end wall 251of sleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 242 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the distal end of sleeve 26 is positioned in a vicinityof a right fibrous trigone 244 of the mitral valve (configuration notshown). Further alternatively, the distal end of the sleeve is notpositioned in the vicinity of either of the trigones, but is insteadpositioned elsewhere in a vicinity of the mitral valve, such as in avicinity of the anterior or posterior commissure. Once positioned at thedesired site near the selected trigone, deployment manipulator 61deploys the first one of anchors 32 through the wall of sleeve 26 (bypenetrating and passing through the wall of the sleeve (i) in adirection parallel to a central longitudinal axis of deploymentmanipulator 61, or anchor driver 36, through the distal end of channel18, and/or (ii) parallel to a central longitudinal axis oftissue-coupling element 60 of anchor 32) into cardiac tissue near thetrigone. Following the deployment of anchor 32 in the cardiac tissue,deployment element 38 is decoupled from anchor 32.

Anchors 32 are typically deployed from a distal end of manipulator 61while the distal end is positioned such that a central longitudinal axisthrough the distal end of manipulator 61 forms an angle with a surfaceof the cardiac tissue of between about 20 and 90 degrees, e.g., between45 and 90 degrees, such as between about 75 and 90 degrees, such asabout 90 degrees. Typically, anchors 32 are deployed from the distal endof manipulator 61 into the atrial surface of the cardiac tissue in adirection parallel to the central longitudinal axis through the distalend of manipulator 61. Such an angle is typically provided and/ormaintained by channel 18 being more rigid than sleeve 26. Distal end 17of channel 18 is typically brought close to the surface of the cardiactissue (and the wall of sleeve 26 that is disposed against the surfaceof the cardiac tissue), such that little of each anchor 32 is exposedfrom channel 18 before penetrating the sleeve and the tissue. Forexample, distal end 17 of channel 18 may be placed (e.g., pushed)against the wall of the sleeve, sandwiching the sleeve against thecardiac tissue.

For some applications, such placement of distal end 17 of channel 18against the cardiac tissue (via the wall of the sleeve), stabilizes thedistal end during deployment and anchoring of each anchor 32, andthereby facilitates anchoring. For some applications, pushing of distalend 17 against the cardiac tissue (via the wall of the sleeve)temporarily deforms the cardiac tissue at the site of contact. Thisdeformation may facilitate identification of the site of contact usingimaging techniques (e.g., by identifying a deformation in the borderbetween cardiac tissue and blood), and thereby may facilitate correctpositioning of the anchor.

That is, typically the entire circular surface of distal end 17 ofchannel 18 is disposed in contact with the wall of sleeve 26 that isdisposed against the surface of the cardiac tissue. As shown, distal end17 is the lower-most circular tip of channel 18 and defines a distalopening of channel 18. In the configuration in which channel 18 ispositioned in order to sandwich the portion of sleeve 26 against annulus240, the distal end 17 is disposed in parallel with a planar surface 255of the tissue of the annulus.

As shown in FIG. 3C, end wall 251 aligns against the tissue of annulus240 in a manner in which a surface of end wall 251 is disposed inparallel with a planar surface of the tissue of annulus 240.Additionally, distal end 17 of implant-decoupling channel 18 flattensend wall 251 against the tissue of annulus 240 in a manner in whichchannel 18 sandwiches end wall 251 between (1) distal end 17 of thechannel, and (2) the portion of the tissue of annulus 240 at the planarsurface into which a first one of anchors 32 is implanted. In such amanner, end wall 251 lies flat against the tissue of annulus 240 inparallel with the planar surface, while at least a distal portion oflateral wall 253 is disposed substantially perpendicularly with respectto the portion of the tissue of annulus 240 at the planar surface intowhich the first one of anchors 32 is implanted.

As shown, anchor 32 is implanted using channel 18 and manipulator 61contained within sleeve 26 of annuloplasty structure 222 while at leasta portion of annuloplasty structure 222 (e.g., a proximal portion) iscontained within surrounding catheter 14.

Reference is now made to FIGS. 2, 3C-D, and 4A-B. Following thedeployment of the first tissue anchor, a distal portion of sleeve 26 isdecoupled from a portion of implant-decoupling channel 18. In order todecouple the portion of sleeve 26 from outer surface of channel 18, (1)channel 18 is pulled proximally, while (2) reference-force tube 19 ismaintained in place in a manner in which a distal end of tube 19provides a reference force to sleeve 26 in order to facilitate freeingof a successive portion of sleeve 26 from around channel 18. In order todecouple sleeve 26 from the outer surface of channel 18, (1) channel 18is pulled proximally, while (2) reference-force tube 19 is maintained inplace. An indicator 2120 on handle 126 provides an indication of howmuch channel 18 is withdrawn from within sleeve 26 (i.e., how much thedelivery tool is decoupled from sleeve 26, and how much the sleeve hasadvanced off channel 18 and against tissue). A proximal end of channel18 is coupled to a knob 94 (FIG. 2) which adjusts an axial position ofchannel 18 proximally and distally with respect to reference-force tube19 and sleeve 26. As shown in FIG. 3D, once the successive portion ofsleeve 26 is freed, deployment manipulator 61 is repositioned alongannulus 240 to another site selected for deployment of a second one ofanchors 32.

FIGS. 4A and 4B are schematic illustrations that show steps between thestate shown in FIG. 3C and the state shown in FIG. 3D, in accordancewith respective applications of the invention. Step C of each of FIGS.4A and 4B shows a state that is generally equivalent to the state shownin FIG. 3D.

For some applications, and as shown in FIG. 4A, anchor driver 36 isdecoupled from anchor 32 and is retracted through channel 18 prior toretracting channel 18 through sleeve 26 and repositioning channel 18.

For some applications, and as shown in FIG. 4B, anchor driver 36 remainscoupled to anchor 32 during the retraction of channel 18 though sleeve26. For some such applications, anchor driver 36 provides a referenceforce (e.g., a distally-directed reference force) that holds in placeanchor 32 and the anchored portion of sleeve 26 while channel 18 isretracted, e.g., reducing a pulling force on anchor 32.

A method is therefore described, comprising: (1) percutaneouslyadvancing toward a tissue of a subject structure 222, while a distalportion of channel 18 is disposed within the lumen defined by sleeve 26,such that a distal opening of the channel is disposed at a first portionof the sleeve; (2) anchoring the first portion of the sleeve to thetissue by using anchor driver 36 to drive tissue-coupling element 60 ofa first anchor 32 through the distal opening of the channel, through thesleeve, and into the tissue; (3) subsequently, while providing adistally-directed reference force to the first anchor 32 via driver 36,proximally withdrawing the distal portion of channel 18 such that thedistal opening of the channel is disposed at a second portion of thesleeve; (4) subsequently, proximally withdrawing driver 36 through thechannel; and (5) subsequently, anchoring the second portion of thesleeve to the tissue by driving tissue-coupling element 60 of a secondanchor 32 through the distal opening of the channel, through sleeve 26,and into the tissue.

Reference is now made to FIGS. 2, 3D, and 4A-B. Such repositioning ofmanipulator 61 is accomplished by performing one or more of thefollowing:

(1) steering distal end portion 112 of catheter 12 (e.g., by steeringknob 210 of handle 22) in the first steering plane, in a manner thatbends portion 112,

(2) steering distal end portion 114 of catheter 14 (e.g., by steeringknob 214 of handle 24) in the second steering plane, in a manner thatportion 112,

(3) axially moving catheter 14 with respect to catheter 12 via knob 216,

(4) axially moving the stand supporting handles 22 and 24 to move bothcatheters 12 and 14,

(5) moving tube 19 and sleeve 26 axially by sliding mount 93 along track90,

(6) by moving channel 18 relative to tube 19 by actuating knob 94.

Typically, the first tissue anchor is deployed most distally in thesleeve (generally at or within a few millimeters of the distal tip ofthe sleeve), and each subsequent anchor is deployed more proximally,such that the sleeve is gradually decoupled from channel 18 ofdeployment manipulator 61 in a distal direction during the anchoringprocedure (i.e., channel 18 is withdrawn from within sleeve 26, andhandle 126 is moved distally so as to retract the tool to make thesuccessive proximal portion sleeve 26 ready for implantation of asubsequent anchor). The already-deployed first one of anchors 32 holdsthe anchored end of sleeve 26 in place, so that the sleeve is drawn fromthe site of the first tissue anchor towards the site of the secondtissue anchor. As sleeve 26 is drawn and decoupled from channel 18, adistal portion 257 of sleeve 26 (i.e., the portion of the sleeve that isproximal to end wall 251) is positioned in a vicinity of tissue ofannulus 240.

FIG. 3D shows distal portion 257 of sleeve 26 (i.e., the portion of thesleeve that is proximal to end wall 251) having been decoupled from aportion of channel 18 by retracting channel 18 proximally. Depending onthe tension applied between the first and second tissue anchor sites,the portion of sleeve 26 therebetween may remain tubular in shape, ormay become flattened.

FIG. 3E shows a second tissue anchor 32 (shown as a second tissue anchor32 b) being deployed through a portion of lateral wall 253 of sleeve 26.The first one of anchors 32 deployed through end wall 251 is labeled asanchor 32 a. Deployment manipulator 61 deploys the second tissue anchorby driving the anchor to penetrate and pass through the wall of sleeve26 into cardiac tissue at the second site.

As shown, anchor 32 b is implanted using channel 18 and manipulator 61contained within sleeve 26 of annuloplasty structure 222 while at leasta portion of annuloplasty structure 222 (e.g., a proximal portion) iscontained within surrounding catheter 14.

As described hereinabove, anchors 32 a and 32 b are each deployed from adistal end of manipulator 61 while the distal end is positioned suchthat a central longitudinal axis through the distal end of manipulator61 forms an angle with a surface of the cardiac tissue of between about20 and 90 degrees, e.g., between 45 and 90 degrees, such as betweenabout 75 and 90 degrees, such as about 90 degrees. Typically, anchors 32are deployed from the distal end of manipulator 61 into the atrialsurface of the cardiac tissue in a direction parallel to the centrallongitudinal axis through the distal end of manipulator 61. Such anangle is typically provided and/or maintained by channel 18 being morerigid than sleeve 26. Distal end 17 of channel 18 is typically broughtclose to the surface of the cardiac tissue (and the wall of sleeve 26that is disposed against the surface of the cardiac tissue), such thatlittle of anchor 32 b is exposed from channel 18 before penetrating thesleeve and the tissue. For example, distal end 17 of channel 18 may beplaced (e.g., pushed) against the wall of the sleeve, sandwiching thesleeve against the cardiac tissue.

As shown in FIGS. 3D-E, a portion of the lateral wall of sleeve 26aligns against the tissue of in a manner in which a surface of theportion of the lateral wall is disposed in parallel with the planarsurface of the tissue. Additionally, distal end 17 of channel 18flattens the portion of the lateral wall against the tissue of annulus240 in a manner in which channel 18 sandwiches the portion of thelateral wall between (1) distal end 17 of implant-decoupling channel,and (2) the portion of the tissue of annulus 240 at the planar surfaceinto which second tissue anchor 32 b is implanted. In such a manner, theportion of the lateral wall being anchored lies flat against the tissueof annulus 240 (parallel with the planar surface thereof), while theremaining portion of the tubular lateral wall is disposed substantiallyperpendicularly with respect to the portion of the tissue into whichsecond tissue anchor 32 b is implanted.

It is to be noted that first and second tissue anchors 32 a and 32 bextend in a substantially same direction and into a common,substantially planar surface of a valve annulus, despite that firsttissue anchor 32 a is deployed through end wall 251 of sleeve 26, andtissue anchor 32 b is deployed through lateral wall 253 of the sleeve.For some applications, anchors 32 a and 32 b are disposed with respectto each other at an angle of between 0 and 45 degrees, e.g., between 0and 30 degrees, e.g., between 0 and 20 degrees.

For some applications, a maximum distance L10 between first tissueanchor 32 a and a point of anchoring of second tissue anchor 32 b isprovided by the length of sleeve 26 that has been decoupled from theportion of channel 18 (e.g., by the distance that channel 18 has beenretracted from sleeve 26, e.g., between 3 and 15 mm, e.g., 8 mm). Thatis, for some applications, second tissue anchor 32 b may be placedanywhere within a circle having a radius that equals L10, centered onthe first tissue anchor (e.g., indicated by arc 1928). For some suchapplications, sleeve 26 thereby serves as a constraining member (e.g., atether) that is used to facilitate positioning of second tissue anchor32 b. Distance L10 is thereby set by the operating physician retractingchannel 18 from sleeve 26 by a particular distance.

FIG. 3F shows the entire length of sleeve 26 having been anchored, via aplurality of anchors 32, to annulus 240, as described hereinabove. Thedeployment manipulator (i.e., deployment manipulator 61 described hereinbut not shown in FIG. 3F) is repositioned along the annulus toadditional sites, at which respective anchors are deployed, until thelast anchor is deployed in a vicinity of right fibrous trigone 244 (orleft fibrous trigone 242 if the anchoring began at the right trigone).Alternatively, the last anchor is not deployed in the vicinity of atrigone, but is instead deployed elsewhere in a vicinity of the mitralvalve, such as in a vicinity of the anterior or posterior commissure.Then, system 10 is removed, leaving behind annuloplasty ring structure222, and guide member 86 coupled thereto.

FIG. 3G shows an adjustment tool 87 being threaded over and advancedalong guide member 86. Adjustment tool 87 typically comprises a rotationtool, and is configured to actuate (e.g., rotate) adjustment mechanism40, so as to tension contraction member 226, and thereby contract sleeve26, as described hereinabove. Typically, adjustment mechanism 40comprises a housing which houses a spool, i.e., a rotatable structure,to which a first end of contraction member 226 is coupled. Typically,the spool is configured to adjust a perimeter of annuloplasty ringstructure 222 by adjusting a degree of tension of contraction member 226that is coupled at a first portion of member 226 to the spool. Thecontraction member 226 extends along sleeve 26 and a second portion ofcontraction member 226 (i.e., a free end portion) is coupled to aportion of sleeve 26 such that upon rotation of the spool in a firstrotational direction, the contraction member is pulled toward adjustmentmechanism 40 in order to contract annuloplasty ring structure 222. It isto be noted that the contraction of structure 222 is reversible. Thatis, rotating the spool in a second rotational direction that opposes thefirst rotational direction used to contract the annuloplasty structure,unwinds a portion of contraction member 226 from around the spool.Unwinding the portion of contraction member 226 from around the spoolthus feeds the portion of contraction member 226 back into sleeve 26 ofstructure 222, thereby slackening the remaining portion of contractionmember 226 that is disposed within the sleeve. Responsively, theannuloplasty structure gradually relaxes and expands (i.e., with respectto its contracted state prior to the unwinding).

Adjustment mechanism 40 typically comprises a locking mechanism thatprevents actuation of the adjustment mechanism (e.g., rotation of thespool) after contraction member 226 has been tightened. For example,locking techniques may be used that are described with reference to FIG.4 of U.S. Pat. No. 8,241,351 to Cabiri.

Tool 87 and is used to rotate the spool of adjustment mechanism 40 inorder to tighten structure 222 by adjusting a degree of tension ofcontraction member 226 (not shown in FIG. 3G). Once the desired level ofadjustment of structure 222 is achieved, e.g., by monitoring the extentof regurgitation of the valve using echocardiography (such as Dopplerechocardiography and/or fluoroscopy), adjustment tool 87 and guidemember 86 are removed from the heart. For some applications, a distalportion of guide member 86 may be left within the heart of the subjectand the proximal end may be accessible outside the body, e.g., using aport. For such applications, adjustment mechanism 40 may be accessed ata later stage following initial implantation and adjustment of ringstructure 222 (e.g., as described with reference to FIGS. 16A-18K).

Alternatively, annuloplasty ring structure 222 is implanted by right orleft thoracotomy, mutatis mutandis.

Reference is again made to FIGS. 3A-G, and is also made to FIGS. 5A-B,which are schematic illustrations of techniques for use with an excessportion 261 of sleeve 26, in accordance with some applications of theinvention. For some applications of the present invention, followingimplantation of sleeve 26 along the annulus, an excess portion 261 ofsleeve 26 may be present at the proximal portion of sleeve. For somesuch applications, excess portion 261 may be anchored to an atrialsurface, such as an atrial wall, using anchors delivered via the lumenof sleeve 26, as described hereinabove, mutatis mutandis, as shown inFIG. 5A.

Alternatively or additionally, excess portion 261 may be anchored to theatrial surface using anchors driven from outside of sleeve 26, laterallythrough the sleeve, such that each anchor passes through the lateralwall of the sleeve twice (e.g., on opposite sides of the lumen of thesleeve), as shown in FIG. 5B. Therefore a method is describedcomprising: (1) percutaneously advancing toward a tissue of a subjectstructure 222, while a distal portion of a channel 18 is disposed withinthe lumen of sleeve 26, such that a distal opening of the channel isdisposed at a first portion of the sleeve; (2) anchoring the firstportion of the sleeve to a first tissue site by using anchor driver 36to drive tissue-coupling element 60 of a first anchor 32 through thedistal opening of the channel, through the first portion of the sleeve(e.g., through end wall 251 or lateral wall 253), and into the firsttissue site; (3) pressing a second portion of the sleeve (i.e., excessportion 261) against a second tissue site; and (4) anchoring the secondportion of the sleeve to the second tissue site by drivingtissue-coupling element 60 of a second anchor 32 from outside the lumen,through opposing sides of the lateral wall at the second portion of thesleeve, and into the second tissue site.

For some applications, when the second portion (i.e., the excessportion) of the sleeve is pressed against the second tissue site (e.g.,the atrial wall) the opposing sides of lateral wall 253 at the secondportion of the sleeve contact each other.

Reference is again made to FIGS. 3A-G. For anatomical reasons, atransluminal (e.g., transfemoral) approach to the mitral valve viatransseptal puncture typically provides access more directly and/oreasily to the region of the anterior commissure (e.g., including leftfibrous trigone 242) than to the region of the posterior commissure(e.g., including right fibrous trigone 244). It may therefore beadvantageous to position and anchor distal end wall 251 of sleeve 26 inthe vicinity of the left fibrous trigone; the positioning of the firstpoint of anchoring of structure 222 may be more difficult than thepositioning of subsequent points of anchoring (e.g., due to guidanceprovided by sleeve 26; FIG. 3E). Due to this same reason ofaccessibility, it may also be advantageous to deliver adjustment tool 87to the region of the anterior commissure (as shown in FIG. 3G).

System 10 (e.g., structure 222 thereof) is configured to facilitateexploitation of these two advantages: By adjustment mechanism 40 beingdisposed at a distal end of sleeve 26, and being movable away from thelongitudinal axis of the sleeve, (1) the first tissue anchor may bedriven through end wall 251 into the region of the anterior commissure,despite the adjustment mechanism having previously been obstructivelypositioned, and (2) the adjustment tool may be delivered to the regionof the anterior commissure because the adjustment mechanism is disposedin that region.

Reference is now further made to FIGS. 6A-B and 7A-B, which areschematic illustrations of steering of catheters 12 and 14, inaccordance with respective applications of the invention. As describedhereinabove, distal end portion 112 of catheter 12 is steerable in afirst steering plane, and distal end portion 114 of catheter 14 issteerable in a second steering plane, typically perpendicular to thefirst steering plane. As also described hereinabove, typically (i)catheter 12 is steered in a steering plane that is parallel with theplane of the annulus of the valve (e.g., as shown in FIG. 6A), and (ii)catheter 14 is steered downward and toward the annulus of the valve(e.g., as shown in FIG. 6B), such that an angle alpha_1 is formedbetween (i) plane 241 of the annulus, and (ii) an exit direction 105from distal end 104 of catheter 14. (Exit direction 105 is typicallycollinear with the central longitudinal axis through the distal end ofmanipulator 61, and/or the central longitudinal axis of tissue-couplingelement 60 of anchor 32.) Typically, angle alpha_1 is greater than anangle alpha_3 formed between plane 241 and an exit direction 103 fromdistal end 102 of catheter 12.

Alternatively, catheter 12 may be steered in a different steering plane,such that catheter 14 may approach the tissue from a different angle,such that an anchor 32 may penetrate the tissue at a different angle ofattack. For example, and as shown in FIG. 7, catheter 12 may be steereddownward and toward the annulus of the valve, and catheter 14 may besteered such that an angle alpha_2 (formed between the plane of theannulus and the central longitudinal axis through the distal end ofmanipulator 61) is smaller than angle alpha_1. For such applications,angle alpha_2 is typically smaller than an angle alpha_4 formed betweenplane 241 and exit direction 103.

Reference is now made to FIGS. 8A-B, 9, 10A-C, 11, and 12A-B, which areschematic illustrations of tissue anchors, and the use of the tissueanchors for implantation of structure 222, in accordance with someapplications of the invention.

FIG. 8A shows tissue anchor 32, described hereinabove. As shown in FIG.8A, tissue-coupling element 60 is typically helical, and has a centrallongitudinal axis 33 (which, when element 60 is helical, is an axis ofrotation of element 60). Tool-engaging head 62 has a width d1, andtissue-coupling element 60 has a width (e.g., a helix diameter) d2 thatfor some applications is about the same as width d1. Width d1 and widthd2 are each smaller than the diameter of the lumen of channel 18,thereby facilitating delivery of anchor 32 through channel 18, asdescribed hereinabove. A greatest transverse width of anchor 32 issmaller than the diameter of the lumen of channel 18.

Width d2 is typically between 0.1 and 0.5 cm (e.g., 0.25 cm). Element 60has a helix length d7 that is typically 0.3-0.9 cm, such as 0.3-0.65 cm(e.g., 0.55 cm), and a helix pitch d8 that is typically 0.05-0.3 cm(e.g., 0.12 cm). Typically, element 60 has a helix wire thickness d9 of0.02-0.1 cm (e.g., 0.05 cm).

FIG. 8B shows a tissue anchor 332, which is typically identical totissue anchor 32 except where noted. Anchor 332 comprises atool-engaging head 362, which is typically (but not necessarily)identical to head 62 of anchor 32. Anchor 332 further comprises atissue-coupling element 360, and has a central longitudinal axis 333. Awidth d3 of head 362 is typically smaller than the diameter of the lumenof channel 18, whereas a width d4 of tissue-coupling element 360 isgreater than the diameter of the lumen of the channel (and is thereforegreater than width d2). For example, widths d1, d2, and d3, and thediameter of the lumen of channel 18 may each be 2-3 mm, and width d4(which is typically the greatest transverse width of anchor 332) may be3-4 mm (e.g., about 3.4 mm). Tissue-coupling element 360 thereforetypically protrudes radially outward from longitudinal axis 333 furtherthan does head 362, by a distance d5. Alternatively, width d3 may alsobe greater than the diameter of the lumen of channel 18.

The larger width of element 360 compared to that of element 60 providesincreased anchoring strength. It is hypothesized that for someapplications this increased anchoring strength is particularly usefulfor the first anchor used to anchor structure 222 (e.g., the anchor thatpenetrates end wall 251), due to increased forces exerted on that anchorcompared to, for example, anchors further along sleeve 26. Due to widthd4 being greater than the diameter of the lumen of channel 18, anchor332 cannot be advanced through channel 18 in the same manner as anchor32. FIGS. 9-12B show techniques for anchoring structure 222 (e.g., thedistal end of sleeve 26) using anchor 332.

Typically, tissue-coupling element 360 has a helix wire thickness thatis generally the same as thickness d9. Tissue-coupling element 360typically has a helix length that is generally the same as length d7.For some applications, a helix pitch d10 of element 360 is different topitch d8. For example, pitch d10 may be smaller than pitch d8, so as tomaintain the helix length of element 360 as generally the same as lengthd7. For some applications, a helix angle alpha_6 (the angle between thehelix and its central longitudinal axis) of element 360 is different toa helix angle alpha_5 of element 60. For example, angle alpha_6 may begreater than angle alpha_5, so as to maintain the helix length ofelement 360 as generally the same as length d7.

At least tissue-coupling element 360 of anchor 332 is disposed outsideof distal end 17 of channel 18 at the time that channel 18 is loadedinto the lumen of the sleeve. For example, deployment element 38 ofanchor driver 36 may be advanced, without an anchor coupled thereto,through channel 18, and subsequently coupled to head 362 of anchor 332.An assembly comprising element 38 (and optionally head 362) may then beretracted into channel 18 before the channel, anchor 332, and driver 36are advanced together into sleeve 26. For some applications, thisassembly is advanced through catheter 14 (and out of the distal endthereof) prior to being advanced into sleeve 26. Therefore,tissue-coupling element 360 does not require passage through channel 18,thereby facilitating the use of anchor 332.

For some applications, and as shown in FIGS. 9-10C, during advancementof structure 222, tissue-coupling element 360 is disposed (i) outside ofdistal end 17 of channel 18, and (ii) inside the lumen of sleeve 26.This may be understood by comparing FIG. 9 with FIG. 1. The steps shownin FIGS. 10A-C generally correspond to the steps shown in FIGS. 3A-C,but with element 360 disposed outside of distal end 17 of channel 18,and inside the lumen of sleeve 26. Subsequent to the anchoring of anchor332 (FIG. 10C), a plurality of anchors 32 are used to anchor theremainder of structure 222, as described hereinabove, mutatis mutandis.

For some applications, and as shown in FIGS. 11-12B, during advancementof structure 222, tissue-coupling element 360 is disposed (i) outside ofdistal end 17 of channel 18, and (ii) outside of sleeve 26, e.g., havingbeen driven through sleeve 26 (e.g., end wall 251 thereof). This may beunderstood by comparing FIG. 11 with FIG. 9 (and/or FIG. 1). The stepsshown in FIGS. 12A-B generally correspond to the steps shown in FIGS.10B-C, but with element 360 disposed outside of sleeve 26. Becauseelement 360 protrudes through sleeve 26, at the time that element 360contacts the tissue, the sleeve is not pressed against the tissue beforedriving anchor 332, and a gap 366 exists between the tissue and thesleeve. Tissue anchor 332 typically has a straight and/or central stemportion 364 that facilitates subsequent closure of this gap by allowingfree rotation of the anchor within the sleeve, e.g., as is known in theart for captive screws. This feature is described in more detail in WO2014/064694 to Sheps et al., which is incorporated herein by reference.

Reference is made to FIGS. 13A-D and 14A-F, which are schematicillustrations of a system 400, comprising a tissue anchor 402, an anchordriver 404, and a lance 406, and techniques for use with the system, inaccordance with some applications of the invention.

Except for where noted, anchor driver 404 is typically identical toanchor driver 36 described herein, and is typically substitutable foranchor driver 36, mutatis mutandis. Except for where noted, tissueanchor 402 is typically identical to tissue anchor 32 described herein,and is substitutable for tissue anchor 32, mutatis mutandis. Anchordriver 404 comprises an elongate shaft 408 (which is typically tubular)and a deployment manipulator 410 coupled to a distal end of the shaft.

System 400 is shown being used to anchor structure 222, but it is to benoted that the scope of the invention includes using system 400 in othersituations that require percutaneous delivery of tissue anchors. Tissueanchor 402 comprises a tissue-coupling element, which in FIGS. 13A-14Fis shown as element 60, but which could comprise a differenttissue-coupling element.

Lance 406 serves two functions: (1) to facilitate reversible locking ofdriver 404 to anchor 402, and (2) to stabilize system 400 at the tissueprior to driving of anchor 402 into the tissue.

System 400 is advanced while a distal tip of lance 406 extends distallypast a distal tip of tissue-coupling element 60 (e.g., in the stateshown in FIG. 13A), such that the lance engages the tissue beforeelement 60 does (FIG. 14A). Lance 406 penetrates the tissue, therebystabilizing system 400 at the tissue. As illustrated by the transitionbetween FIG. 14A and FIG. 14B, for some applications system 400 is usedin combination with a catheter system that facilitates pivoting (i.e.,deflection) of system 400 about the point at which lance 406 penetratesthe tissue. For example, such a catheter system may comprise catheter 14(as shown), catheter 12, and/or other elements of system 10. It ishypothesized that this facilitates separation between (i) correctlylocating anchor 402 at the anchor site, and (ii) correctly orienting theanchor with respect to the tissue at the anchor site. That is, lance 406can penetrate the tissue at the correct location but the incorrectorientation (e.g., angle) (FIG. 14A), and system 400 can be subsequentlydeflected about that location (e.g., using the lance as a pivot) so asto obtain the correct orientation (e.g., the correct angle of attack foranchor 402) (FIG. 14B).

Anchor 402 is typically driven at least partway into the tissue beforepartially retracting lance 406 (FIGS. 14C-D). FIG. 13B shows lance 406in this partly retracted position. The presence of lance 406 withindeployment manipulator 410 retains the deployment manipulator locked toanchor 402 (e.g., to a tool-engaging head 412 thereof). For example, andas shown, deployment manipulator 410 may comprise one or more detents414 that are held in a locking position (e.g., radially outward) bylance 406. The partial retraction of lance 406 shown in FIG. 13B doesnot remove the lance from deployment manipulator 410, and so themanipulator remains locked to anchor 402.

FIG. 14D shows anchor 402 fully anchored to the tissue, and lance 406partially retracted. Subsequent to the anchoring, lance 406 is retractedfurther, thereby unlocking deployment manipulator 410 from anchor 402(FIG. 14E), e.g., due to detents 414 responsively moving radiallyinward, as shown in FIG. 13C. Driver 404 may then be decoupled fromanchor 402 (FIGS. 14F and 13D).

Apparatus is therefore described, comprising (1) an anchor, comprising(a) an anchor head, and (b) a tissue-engaging member, coupled to theanchor head, extending distally away from the anchor head until a distaltip of the tissue-engaging member, and configured to anchor the anchorto the tissue; (2) an anchor driver, comprising: (a) a longitudinalshaft, having a flexible distal portion and a distal end, (b) adeployment element at the distal end of the shaft, reversibly lockableto the anchor head, and reversibly movable between (i) a locked statethat retains locking between the deployment element and the anchor head,and (ii) an unlocked state that unlocks the deployment element from theanchor head, and (c) a tissue-piercing lance, reversibly movable betweenan extended state in which (i) the lance extends distally from theshaft, (ii) while the deployment element is locked to the anchor head,the lance extends distally past the distal tip of the anchor, and (iii)the lance retains the deployment element in the locked state, and aretracted state in which the deployment element automatically moves intothe unlocked state.

Apparatus is therefore also described, comprising (1) a percutaneouscatheter; (2) an implant, dimensioned to be advanced into the subjectvia the catheter; (3) an anchor-delivery channel, shaped to define alumen therethrough, the lumen having a diameter, and the channel beingdimensioned to be disposable within the catheter; (4) at least oneanchor, comprising an anchor head coupled to a tissue-coupling element,the anchor head defining an aperture therethrough, and (5) an anchordriver (i) comprising a stem, and a driver head coupled to the distalend of the stem, the driver head being reversibly couplable to theanchor head, (ii) configured to advance the anchor through the lumen ofthe channel while the driver head is coupled to the anchor head, (iii)further comprising a lance that is reversibly extendable with respect tothe driver head, such that when the driver head is coupled to the anchorhead, extension of the lance causes the lance to slide through theaperture such that a tip of the lance becomes disposed distally beyond adistal tip of the tissue-engaging element, and (iv) configured to drivethe tip of the lance through a portion of the implant and into thetissue of the subject, and to drive the tissue-coupling element of theanchor through the portion of the implant and into the tissue of thesubject, independently of the driving of the tip of the lance.

Apparatus is therefore also described, comprising (1) an anchor,comprising (i) an anchor head, having a proximal side and a distal side,and defining an aperture from the proximal side to the distal side, (ii)a tissue-engaging member, coupled to the anchor head, extending distallyaway from the anchor head until a distal tip of the tissue-engagingmember, and configured to anchor the anchor to the tissue; (2) an anchordriver, comprising (i) a longitudinal shaft, having a flexible distalportion and a distal end, (ii) a tissue-piercing lance, reversiblyextendible distally from the shaft, (iii) a deployment element coupledto the distal end of the shaft, and reversibly couplable to the anchorhead in a position in which extension of the lance distally from theshaft moves the lance through the aperture and past the distal tip ofthe anchor; and (3) a catheter system, comprising (i) a catheter throughwhich the anchor driver is intracorporeally advanceable (a) while thedeployment element is coupled to the anchor head, and (b) such that thedistal portion of the shaft extends distally out of the catheter, andhaving a distal segment that is intracorporeally deflectable withrespect to another segment of the catheter immediately proximal to thedistal segment, and (ii) an extracorporeal controller configured, whilethe distal portion of the shaft is extended distally out of thecatheter, and the lance is extended distally from the shaft and isdisposed in the tissue, to cause deflection of the distal segment withrespect to the other segment, such that the distal portion of the shaftdeflects with respect to another portion of the shaft immediatelyproximal to the distal portion, the anchor driver being configured todrive the tissue-engaging member into the tissue while the distalportion of the shaft is deflected with respect to the other portion ofthe shaft.

A method is therefore also described, comprising (1) advancing a distalend of an anchor driver through a catheter and toward a tissue of asubject, the anchor driver including a shaft, a tissue-piercing lance,and a deployment element; (2) subsequently, piercing the tissue with thelance; (3) deflecting a distal portion of the shaft with respect toanother portion of the shaft immediately proximal to the distal portion,by moving a distal segment of the catheter while at least some of thelance is disposed within the tissue; and (4) while (i) the distalportion of the shaft is deflected with respect to the other portion ofthe shaft, and (ii) the deployment element is locked to a head of ananchor, driving a tissue-engaging member of the anchor into the tissueusing the anchor driver.

Reference is made to FIGS. 15A-B, which are schematic illustrations ofimplants 422 a and 422 b that each comprise a contracting wire, inaccordance with some applications of the invention. Each of implants 422a and 422 b comprise an annuloplasty structure that comprises (1) asleeve, having a first end and a second end, a bearing site, andcomprising a lateral wall that defines a lumen from the first end to thesecond end, (2) adjustment mechanism 40, and (3) a contraction member(a) having a first end coupled to the adjustment mechanism, (b) having afirst portion that extends from the adjustment mechanism along thesleeve toward the second end, until the bearing site, and (c) having asecond portion that extends from the bearing site back toward theadjustment mechanism and the first end, the adjustment mechanism beingconfigured to reduce a length of the sleeve between the first end andthe second end by pulling on the first portion of the contraction membersuch that the second portion of the contraction member progressivelyslides past the bearing site.

Typically, implants 422 a and 422 b are identical to structure 222,except where noted, and may be used, in place of structure 222, intechniques described herein. Similarly, the sleeve of each implant istypically identical to sleeve 26, mutatis mutandis, and the referencenumeral 26 is also used for these sleeves.

Implant 422 a comprises a contraction member 426 a. A first end ofcontraction member 426 a is coupled to mechanism 40. A first portion 424a of contraction member 426 a extends from mechanism 40 through thelumen of sleeve 26 toward proximal end 252 of the sleeve, until abearing site 430. A second portion 428 a of contraction member 426 aextends from bearing site 430 back toward adjustment mechanism 40 andthe distal end of the sleeve (e.g., end wall 251), weaving throughlateral wall 253 of sleeve 26.

Implant 422 b comprises a contraction member 426 b. A first end ofcontraction member 426 b is coupled to mechanism 40. A first portion 424b of contraction member 426 a extends from mechanism 40 toward proximalend 252 of sleeve 26, weaving through lateral wall 253, until a bearingsite 430. A second portion 428 b of contraction member 426 a extendsfrom bearing site 430 back toward adjustment mechanism 40 and the distalend of the sleeve (e.g., end wall 251), weaving through lateral wall 253of sleeve 26. Implant 422 b is typically identical to implant 422 a,except that the first portion of contraction member 426 b also weavesthrough lateral wall 253 of sleeve 26.

For each of implants 422 a and 422 b, when adjustment mechanism 40tensions the contraction member, the second portion of the contractionmember progressively slides past (e.g., through) bearing site 430. (Thistypically occurs as bearing site 430 moves toward adjustment mechanism40 due to the contraction of the implant). Typically, and as shown,bearing site 430 is defined by a hole in sleeve 26, reinforced by aneyelet (e.g., a metal ring, such as a grommet). For some applications,bearing site 430 may comprise a different bearing, such as a wheel(e.g., a sheave). It is to be noted that for both implant 422 a andimplant 422 b, both the first portion and the second portion of thecontraction member become shortened during contraction of sleeve 26.

Typically, for both implant 422 a and implant 422 b, the first portionof the contraction member enters sleeve 26 via a hole in the sleeve,reinforced by an eyelet (e.g., a metal ring, such as a grommet). Thishole may also serve as a bearing site 431, through which the firstportion of the contraction member slides when adjustment mechanism 40tensions the contraction member.

Typically, a second end 429 of the contraction member (i.e., the end notcoupled to adjustment mechanism 40) is fixedly coupled to the sleeve(e.g., using a crimp bead, as shown).

Reference is made to FIGS. 16A-B, 17A-C and 18A-K, which are schematicillustrations of a system 440 for docking with and adjusting anadjustment mechanism of a percutaneously-implantable implant, andtechniques for use therewith, in accordance with some applications ofthe invention.

Apparatus is described, comprising: (1) a percutaneously-implantableimplant (e.g., annuloplasty ring structure 222, comprising sleeve 26);(2) an adjustment device 442, comprising (i) an adjustment mechanism(e.g., mechanism 40), coupled to the implant, and configured to change adimension of the implant upon actuation of the adjustment mechanism; and(ii) a lock 444, (a) having a locked state in which the lock inhibitsactuation of the adjustment mechanism, (b) having an unlocked state inwhich the adjustment mechanism is actuatable, and (c) reversibly movablebetween the locked state and the unlocked state; (3) a longitudinalguide member (e.g., guide member 86); and (4) an adapter 446: (i)coupled to the guide member, (ii) comprising a fastener 448 that couplesthe adapter to the adjustment device, and is intracorporeallydecouplable from the adjustment device, (iii) configured to bepercutaneously delivered while coupled to the adjustment device, and(iv) comprising an unlocking mechanism 450, configured such that, whilethe adapter is coupled to the adjustment device, actuation of theunlocking mechanism moves the lock between the locked state and theunlocked state.

FIGS. 16A-B are schematic illustrations of adapter 446 coupled toadjustment device 442, in accordance with some applications of theinvention. As described hereinbelow, adapter 446 is typically coupled toadjustment device 442 before delivery and implantation of the implant(e.g., the adapter is provided pre-coupled to device 442, or is coupledto device 442 by the physician prior to implantation), and the implantis delivered and implanted with adapter 446 coupled to device 442. FIG.16A shows an exploded view of adjustment device 442 and adapter 446, andFIG. 16B shows an assembled view, with the adapter coupled to theadjustment device.

Adapter 446 comprises a trunk 452 (i.e., a main body portion) that iscoupled to fastener 448. Typically, unlocking mechanism 450 comprises apin disposed in a channel, and actuation of the unlocking mechanism tounlock lock 444 of adjustment device 442 (described hereinbelow)comprises sliding of the pin within the channel. For some applications,and as shown, at least part of this channel is defined by fastener 448.For some applications, and as shown, at least part of this channel isdefined by trunk 452. Trunk 452 typically comprises a lateral opening474 through which an appendage 451 of the pin protrudes.

Lock 444 comprises a depressible portion 443 that defines, or is coupledto, a detent 445, and is unlocked by unlocking mechanism 450 pressing onthe depressible portion, thereby moving the detent, as describedhereinbelow.

Trunk 452 is shaped such that an external shape of a transversecross-section of at least a proximal portion of the trunk (the upperportion as shown in the figures) is non-circular. This facilitatesapplication of torque to trunk 452, so as to decouple (e.g., unscrew)adapter 446 from adjustment device 442, as described hereinbelow.

For some applications, and as shown, fastener 448 is shaped to define ascrew thread that screws into a corresponding screw thread defined byadjustment device 442, and adapter 446 is decouplable from adjustmentdevice 442 by unscrewing.

FIGS. 17A-C are schematic illustrations of an adjustment tool 460, inaccordance with some applications of the invention. Adjustment tool 460is percutaneously advanceable along guide member 86 to adapter 446subsequently to implantation of structure 222, and comprises (i) anadjustment-mechanism interface 462, dimensioned to interface with (e.g.,to engage) mechanism 40, and (ii) an adapter interface 464, dimensionedto interface with (e.g., to engage) adapter 446, and comprising a forceapplicator 466. For some applications, and as shown, force applicator466 is defined by a distal portion of adapter interface 464. Tool 460 isconfigured (1) to move lock 444 into its unlocked state by, whileadapter 446 is coupled to adjustment device 442, actuating unlockingmechanism 450 by applying, with force applicator 466, a force to theunlocking mechanism, and (2) to actuate adjustment mechanism 40 via theinterface between adjustment-mechanism interface 462 and the adjustmentmechanism. Typically, tool 460 is also configured to decouple adapter446 from adjustment device 442.

For some applications, and as shown, force applicator 466 is axiallyslidable with respect to adapter 446, and is configured to actuateunlocking mechanism 450 by applying an axial force (e.g., a distalforce) to the unlocking mechanism. For such applications, adapterinterface 464 (or at least applicator 466 thereof) is typically axiallyslidable with respect to adjustment-mechanism interface 462. FIG. 17Ashows force applicator 466 slid axially distally with respect tointerface 462, and FIGS. 17B-C show (in isometric and cutaway views,respectively) the force applicator slid axially proximally with respectto interface 462, e.g., such that the force applicator is disposedwithin a tubular portion 468 of interface 462. This sliding is typicallydriven via a control rod 470, coupled to adapter interface 464 andaccessible from outside the subject, e.g., extending from the adapterinterface to outside the subject, such as to a handle of tool 460 (notshown).

For some applications, and as shown, the slidability of tool 460 alongguide member 86 is provided by rod 470 being tubular and being slidableover rod 470. For some applications, and as shown, movement ofadjustment-mechanism interface 462 is facilitated via an outer tube 472,a distal end of which may define interface 462, and tubular portion 468.

As described hereinabove, contraction of structure 222 may be performedwhile monitoring the heart (e.g., using Doppler echocardiography) so asto determine a desired amount of contraction (typically an amount ofcontraction that results in the least regurgitation). It is hypothesizedthat for some applications, contact between the adjustment tool and theadjustment mechanism may interfere with such monitoring, e.g., byapplying a force that temporarily deforms the anatomy of the valve. Asdescribed hereinbelow, system 440 provides reversible and repeatablecoupling of adjustment tool 460 to adjustment device 442, and repeatableunlocking, adjustment and relocking of the adjustment device (e.g., ofadjustment mechanism 40 thereof), and thereby facilitates suchmonitoring by allowing the monitoring to be performed while theadjustment tool is not in contact with the adjustment device.

FIGS. 18A-K show techniques for use with system 440, in accordance withsome applications of the invention. FIG. 18A shows structure 222 havingbeen implanted at valve 230. Adapter 446 is coupled to adjustment device442; structure 222 is typically percutaneously advanced and implantedwhile the adapter is coupled to the adjustment device.

Subsequently, tool 460 is advanced over guide member 86 towardadjustment device 442, as described for tool 87, mutatis mutandis (FIG.18B). Adapter interface 464 is slidable over trunk 452 to a sufficientextent that force applicator 466 reaches appendage 451. For someapplications, and as shown, a distal portion of adapter interface 464(e.g., force applicator 466) is angled such that, in response to slidingof the adapter interface axially over the proximal portion of trunk 452,the adapter interface automatically assumes a pre-determined rotationalorientation with respect to the trunk; typically such that the forceapplicator aligns with appendage 451. For some applications, and asshown, a proximal portion of adapter 446 is angled such that, inresponse to sliding of adapter interface 464 axially over the proximalportion of trunk 452, the adapter interface automatically assumes thepre-determined rotational orientation. For example, and as shown, trunk452 may define one or more shoulders 454 that are angled in this way.

This automatic rotational alignment is illustrated by FIGS. 18C-E. InFIG. 18C, tool 460 arrives at adapter 446 with adapter interface 464 andforce applicator 466 misaligned. For example, adapter interface 464 isrotationally oriented such that force applicator 466 is not aligned withappendage 451. FIG. 18D shows that, in response to further axial slidingof adapter interface 464 over trunk 452, the adapter interfaceautomatically rotates into the pre-determined orientation in which forceapplicator 466 aligns with appendage 451. As described hereinabove, thismay be facilitated by an angled portion of adapter interface 464 and/oran angled portion of trunk 452. FIG. 18E shows further axial advancementof tool 460, such that adjustment-mechanism interface 462 interfaceswith adjustment mechanism 40. As shown, at this time, lock 444 islocked, e.g., with detent 445 inhibiting actuation (e.g., rotation) ofadjustment mechanism 40.

Subsequently, force applicator 466 actuates unlocking mechanism 450(e.g., by applying an axial force thereto, such as via appendage 451),which responsively unlocks lock 444 (FIG. 18F). For example, and asshown, the pin of unlocking mechanism 450 may slide axially within itschannel, and press on depressible portion 443 of lock 444, therebydisengaging detent 445 from adjustment mechanism 40. It is to be notedthat, while (i) adapter interface 464 is disposed over trunk 452, and(ii) force applicator 466 is in contact with unlocking mechanism 450(e.g., appendage 451 thereof), the non-circular shape of the trunkinhibits the adapter interface from rotating further in response tofurther sliding of the adapter interface axially over the trunk. Forexample, the angle of force applicator 466 that causes adapter interface464 to rotate when axially pushed over trunk 452 may also provide arotational force to the adapter interface when axially pushed againstappendage 451. Such rotational force is resisted by the non-circularshape of trunk 452, and a corresponding (e.g., mating) shape of adapterinterface 464.

While lock 444 is unlocked, adjustment-mechanism interface 462 actuatesadjustment mechanism 40, thereby changing a dimension of the implant(e.g., contracting the implant), e.g., by adjusting tension ofcontraction member 226 (FIG. 18G).

After this adjustment, tool 460 is retracted along guide member 86 awayfrom structure 222, e.g., partially or completely into catheter 12,while the guide member remains coupled to the implant (e.g., coupled toadjustment device 442 via adapter 446) (FIG. 18H). At this time, lock444 is in a locked state, having been relocked prior to de-interfacing(e.g., disengagement) of adjustment-mechanism interface 462 fromadjustment mechanism 40. For some applications, lock 444 is activelylocked by a force applied thereto by unlocking mechanism 450. However,lock 444 is typically biased to be in its locked state, and soautomatically locks upon removal of the pressing force, e.g., byretracting force applicator 466, or by retracting tool 460 as a whole.

In this state, the anatomical and/or functional condition of valve 230is observed, e.g., using Doppler echocardiography (as illustrated by theinset schematic in FIG. 18H), or another imaging technique, so as todetermine whether a desired amount of contraction has been achieved. Forexample, regurgitation from valve 230 may be observed, so as todetermine whether the regurgitation has been sufficiently reduced (e.g.,eliminated). Tool 460 may then be returned to adjustment device 442, andreadjustment performed (18I).

System 440 facilitates repeated cycles of engagement with, adjustmentof, and disengagement from adjustment device 442. It is hypothesizedthat for some applications, in the absence of the locking of lock 444before (or upon) each disengagement, structure 222 might return at leastpartway toward its previous shape or size. For example, in the absenceof this locking, a tendency of the native annulus to return toward itsprevious circumference might otherwise cause contraction member 226 tounspool from adjustment mechanism 40 each time that adjustment-mechanisminterface 462 disengages from the adjustment mechanism. Additionally,the independence between (i) the decoupling of guide member 86 fromadjustment device 442, and (ii) the unlocking and locking of lock 444further facilitates repeated retraction and re-engagement of tool 460.Together, these features facilitate (i) post-adjustment observation ofthe condition of valve 230 in the absence of force applied to the valveand/or to structure 222 by tool 460, and (ii) subsequent readjustment ofthe implant at least in part responsively to that observation.

Once a desired amount of adjustment has been achieved, tool 460 is usedto decouple adapter 446 (and thereby guide member 86) from adjustmentdevice 442. Typically, this is achieved by (i) rotating adapter 446(e.g., by applying torque to trunk 452) using adapter interface 464,while (ii) providing a reference force to adjustment device 442 (e.g.,holding driving interface 476 still) using adjustment-mechanisminterface 462, thereby decoupling (e.g., unscrewing) fastener 448 fromthe adjustment device (FIG. 18J). Tool 460 and guide member 86 are thenwithdrawn from the subject (FIG. 18K).

For some applications, adapter 446 (and thereby guide member 86) are notdecoupled from adjustment device 442 at the end of the procedure, and aproximal end of guide member 86 remains accessible from outside thebody, e.g., using a port. For such applications, adjustment mechanism 40may be accessed and readjusted during a subsequent procedure.

Reference is made to FIGS. 19A-F, which are schematic illustrations of aforce gauge 500, and techniques for use thereof, in accordance with someapplications of the invention. It is hypothesized that for someapplications it is advantageous to test the anchoring strength ofindividual anchors subsequent to their anchoring, and prior to anchoringof a subsequent anchor. For some applications this is achieved using aforce gauge such as force gauge 2800 described in PCT applicationpublication WO 2014/064694, which is incorporated herein by reference inits entirety. For some applications, and as described with reference toFIGS. 19A-F, this is achieved using force gauge 500.

A method is described, comprising: (1) using implant-manipulating handle126, coupled to structure 222 (via reference-force tube 19), topercutaneously advance structure 222 toward the implant site (e.g., asdescribed hereinabove); (2) by applying a first force to theimplant-manipulating handle, sliding the implant with respect tocatheter 14 without causing the implant to apply force to tissue at theimplant site (FIG. 19B); (3) measuring a magnitude of the first force(FIG. 19B); (4) subsequently, anchoring the implant to tissue at theimplant site (FIG. 19E); (5) subsequently, by applying a second force tothe implant-manipulating handle, causing the implant to apply a thirdforce to tissue at the implant site via the anchoring of the implant(FIG. 19F); (6) measuring a magnitude of the second force; and (7)determining a magnitude of the third force at least in part responsivelyto a difference between the magnitude of the first force and themagnitude of the second force.

Force gauge 500 is provided on handle 126, and is coupled to structure222 via reference-force tube 19. Gauge 500 indicates the strength of aforce (e.g., a pulling force) applied to structure 222 via the gauge.For some applications, and as shown, gauge 500 comprises a grip 502,which facilitates applying the force to structure 222 using handle 126in a similar manner to if the gauge were absent.

FIG. 19A shows a state of structure 222 being implanted at valve 230, inwhich (i) a first anchor 32 has been used to anchor the distal end ofsleeve 26 to annulus 240, (ii) a successive portion of sleeve 26 hasbeen freed from channel 18, and (iii) channel 18 is in position toanchor a second anchor, sandwiching sleeve 26 against the tissue. Thestate shown in FIG. 19A is typically the same as that shown in FIG. 3D,mutatis mutandis.

Prior to anchoring the second anchor, structure 222 is slid with respectto catheter 14 by applying a force via grip 502, without causing theimplant to apply force to tissue at the implant site. FIG. 19B showsgrip 502 being pulled proximally such that reference-force tube 19 (andthereby a proximal portion of sleeve 26, which is coupled thereto) andchannel 18 (disposed through tube 19) are together pulled proximally.(Tube 19 and channel 18 do not move with respect to each other becauseknob 94 remains stationary.) The pulling is typically stopped as soon asmovement of handle 126 is observed, and the portion of sleeve 26disposed between channel 18 and the first anchor is typically nottensioned, therefore structure 222 is not caused to apply force to thetissue. The force required to cause handle 126 to move proximally ismeasured using an indicator 504 of gauge 500. Indicator 504 is typicallya peak force indicator, which continues to indicate the maximum forceexperienced when that force is no longer present. Frame (i) of FIG. 19Bshows indicator 504 indicating “0” on a scale 506, prior to pulling ongrip 502, and frame (ii) shows indicator 504 indicating “1” on scale506, subsequent to pulling on the grip.

Because no force is applied to the tissue (e.g., because the portion ofsleeve 26 disposed between channel 18 and the first anchor is nottensioned), the measured force is indicative of friction between (i)tube 19 (and in some cases a proximal portion of sleeve 26), and (ii)catheter 14. Such friction is typically present in transcathetersystems, and for some applications, as described hereinabove, suchfriction is intentionally provided so as to reduce a likelihood ofinadvertent sliding of tube 19 through catheter 14. Typically, the forcerequired to overcome static friction (i.e., that required to initiatethe sliding of the implant) is greater than that required to overcomekinetic friction (i.e., that required to maintain sliding of theimplant). Therefore measurement of the force is possible even if thepulling is stopped as soon as movement of handle 126 is observed. Thistherefore facilitates avoiding applying force to the tissue viastructure 222 (which (i) might otherwise occur if a greater degree ofmovement were required, and (ii) would interfere with measurement offriction alone).

As described hereinabove, the force used to slide the implant withoutcausing the implant to apply force to the tissue is subsequentlycompared with a force used to apply force to the tissue via thepreviously-implanted anchor (FIG. 19F). The result of this comparison isindicative of the magnitude of the net force applied to the anchor viasleeve 26 (i.e., the total force applied, minus the force required toovercome friction). Successfully pulling on the anchor with a forcegreater than a pre-determined threshold force, without the anchorbecoming de-anchored, is indicative of successful anchoring of theanchor. Gauge 500 facilitates accurately identifying that thepre-determined threshold force has been achieved, thereby allowing theoperator not to pull harder than is necessary to identify this. Gauge500 therefore reduces the likelihood of applying an unnecessarily strongpulling force to the anchor via sleeve 26.

FIGS. 19B-C show an application of the invention for facilitating thecomparison of the pre- and post-anchoring forces. For such anapplication, scale 506 is zeroable (e.g., resettable). Once thepre-anchoring force is measured (FIG. 19B), scale 506 is zeroed to thevalue indicated by peak indicator 504. This is shown by the sliding ofscale 506 in FIG. 19C, but it to be noted that the scope of the presentinvention includes other techniques for zeroing a scale. Therefore, theindicated post-anchoring force shown in FIG. 19F is the net forceapplied to the anchor via sleeve 26, ignoring the force required toovercome friction.

For some applications, a force gauge is alternatively or additionallyprovided on a proximal portion of anchor driver 36 (not shown). In thiscase, the anchor could be pulled directly, rather than via sleeve 26.However, for applications in which channel 18 remains sandwiching sleeve26 against the tissue until after anchor driver 36 is decoupled fromanchor 32 (e.g., illustrated by FIG. 3C and step (A) of FIG. 4A, insequence), resistance to the pulling may disadvantageously be providedthe channel, making accurate measurement difficult. For someapplications in which channel 18 is withdrawn prior to decoupling ofanchor driver 36 from anchor 32 (e.g., illustrated by FIG. 3C and step(A) of FIG. 4B, in sequence), this disadvantage may not apply.

FIGS. 19A-F show the measured force as a pulling force. However for someapplications, the measured force (or at least one measured force) is apushing force. It is hypothesized that for some applications theresistance (e.g., friction) between (i) tube 19 (and optionally part ofsleeve 26) and (ii) catheter 14 is generally equal in either axialdirection. For some such applications, the pre-anchoring measured forceis a pushing force, which is used in the same way, mutatis mutandis, todetermine the net force applied to the anchor. It is hypothesized thatfor some applications this advantageously facilitates measurement of thepre-anchoring force during the movement of channel 18 and sleeve 26toward the anchoring site (e.g., illustrated by the transition from stepB to step C of FIGS. 4A and 4B), thereby shortening the overallprocedure by eliminating the step shown in FIG. 19B.

Alternatively or additionally, such measurement of resistance to apushing force may be used to confirm successful positioning of thedistal end of channel 18 against tissue. For example, distal movement ofthe distal end of channel 18 (and/or if handle 126) before the appliedpushing force reaches a particular threshold, may indicate that channel18 was placed against weaker tissue (e.g., leaflet tissue), whereashigher resistance may indicate that the tube was placed against strongertissue (e.g., annulus 240, or a fibrous trigone).

Reference is now made to FIG. 20, which is a schematic illustration of asystem 600 comprising an implant configured for delivery into a heart ofa subject, in accordance with some applications of the presentinvention. The implant comprises annuloplasty ring structure 222 (i.e.,an implant, e.g., an annuloplasty band) comprising flexible sleeve 26(as described hereinabove with reference to FIG. 1). As describedhereinabove, structure 222 comprises contraction member 226 that extendsalong sleeve 26.

As shown in the lower image of FIG. 20, during anchoring of sleeve 26along the circumference of annulus 240, with each successive deploymentof anchors 32, sleeve 26 gets successively twisted helically around itslongitudinal axis at the point of entry of each successive anchor 32.That is, with each successive deployment of anchor 32, tension andtorsion of sleeve 26 increases as it is positioned circumferentiallyaround annulus 240. Since contraction member 226 is threaded throughsleeve 26, as the sleeve twists, the twist and torsion of sleeve 26causes contraction member 226 to assume a helical path with respect tothe tissue of annulus 240. In response to twisting of the sleeve, partsof contraction member 226 are disposed further away from the tissue(i.e., the parts of member 226 at the parts of sleeve 26 that arepositioned first against the annulus), while other parts of contractionmember 226 are disposed closer to the tissue of annulus 240 (i.e., theparts of member 226 at the parts of sleeve 26 that are positioned lateragainst the annulus, after the sleeve assumes a curved shapecorresponding to the curve of the annulus 240). Thus, the twisting ofsome parts of sleeve 26, for a given part of the sleeve 26, a part ofcontraction member 226 is brought in line with and against tissue ofannulus 240, and in some cases, in the path of anchor 32 passing throughthat part of sleeve 26. In such a case, the part of contraction member226 is likely to become entangled with anchor 32 passing through thatpart of sleeve 26, and ultimately, compromising the smooth tensioning ofcontraction member 226 in response to actuation of adjustment mechanism40. For some applications, the entangling of contraction member 226 withanchor 32 increases friction between the part of contraction member 226and the part of sleeve 26.

Reference is now made to FIG. 21, which is a schematic illustration of asystem 610 comprising an implant configured for delivery into a heart ofa subject, in accordance with some applications of the presentinvention. The implant comprises annuloplasty ring structure 611 (i.e.,an implant, e.g., an annuloplasty band) comprising a flexible sleeve 26defining a primary body portion 750 of structure 611. It is to be notedthat annuloplasty structure 611 is similar to structure 222 as describedthroughout the application and specifically, hereinabove with referenceto FIG. 1, with the exception of the coupling of contraction member 226with respect to sleeve 26, as is described hereinbelow.

Contraction member 226 of structure 611 has a first end portion that iscoupled to adjustment mechanism 40 and a second end portion that iscoupled to a portion of a body portion 615 of structure 611. Member 226defines a first longitudinal portion 612 extending from the first endportion and through a contracting portion of body portion 615 ofstructure 611. First longitudinal portion 612 extends along a firstlongitudinal path. For some applications, the first longitudinal path isparallel with respect to a longitudinal axis of body portion 615 whenstructure 611 assumes a linear shape and when structure 611 is in astate in which no torsion or twisting is applied to sleeve 26. For someapplications of the present invention, and as shown in FIG. 21, bodyportion 615 comprises sleeve 26. Member 226 also defines a secondlongitudinal portion 616 extending through the contracting portion ofbody portion 615 of structure 611 and to the second end portion ofmember 226. Second longitudinal portion 616 extends along a secondlongitudinal path that is offset with respect to the first longitudinalpath when structure 611 is in a state in which no torsion or twisting isapplied to sleeve 26. For some applications, the second longitudinalpath is parallel with respect to a longitudinal axis of body portion 615when structure 611 assumes a linear shape. Additionally, member 226defines an offsetting portion 614 which offsets first and secondlongitudinal portions 612 and 616 of contraction member 226.

For some applications of the present invention, offsetting portion 614extends along a stepped path when structure 611 is in a state in whichno torsion or twisting is applied to sleeve 26. For some applications ofthe present invention, offsetting portion 614 extends along a helicalpath. For some applications of the prevent invention, contraction member226 is coupled to sleeve 26 in a manner in which at least a part ofcontraction member 226 is disposed helically around longitudinal axis Aof sleeve 26 of structure 222. For some applications, portion 614defines at least between 1-5%, e.g., between 1-2%, of contraction member226 that is disposed helically around longitudinal axis A.

For some applications, and as shown in FIG. 21, body portion 615 ofannuloplasty structure 611 comprises is tubular and first and secondlongitudinal portions 612 and 616 are offset by a distance Di1 of0.3-0.7 radians, e.g., 0.5 radians. For some applications, first andsecond longitudinal portions 612 and 616 are offset by a distance of0.8-1.2 mm, e.g., 1 mm.

For some applications of the present invention, first and secondlongitudinal portions 612 and 616 and offsetting portion 614 arethreaded in and out of a woven material of sleeve 26.

Sleeve 26, for some applications, comprises a flexible tubular wall thatcircumscribes a central longitudinal axis of sleeve 26 when structure611 assumes a linear shape. Sleeve 26 has a lumen having a distal end(i.e., at end wall 251 of sleeve 26), a proximal end, and a lengththerebetween. Contraction member 226 is coupled to sleeve 26 such thattensioning contraction member 226 reduces a length of the lumen.Contraction member 226 is woven, or threaded, through the lateral wallsuch that, in an absence of torsion of the sleeve around thelongitudinal axis, as shown in the upper image of FIG. 21, at least partof contraction member 226 is disposed helically around the longitudinalaxis.

Once sleeve 26 is curved to correspond to the shape of annulus 240,sleeve 26 is naturally twisted during the curving, as describedhereinabove with reference to FIG. 20. Even during and following thetwisting of sleeve 26, offsetting portion 614 enables secondlongitudinal portion 616 of member 226 to either (1) face the atriumand/or (2) face a center C of structure 611 following the curving ofstructure 611 to correspond to the shape of annulus 240. As such,portion 616 is positioned away from the portion of sleeve 26 that isagainst the tissue of annulus 240 and away from any path of anchor 32that passes through the portion of sleeve 26 that is against the tissueof annulus 240.

Additionally, since offsetting portion 614 enables second longitudinalportion 616 of member 226 to either face center C of structure 611following the curving of structure 611 to correspond to the shape ofannulus 240, contraction member 226 extends more uniformly along theinner wall of sleeve 26 facing center C, once structure 611 is curved tocorrespond to the shape of the annulus. That is, portion 616 is notdisposed helically with respect to the tissue, nor is any section ofportion 616 disposed against tissue of annulus 240. With this moreuniform extending of member 226 along the inner wall of sleeve 26 facingcenter C, once structure 611 is curved to correspond to the shape of theannulus, contraction member 226 is able to more uniformly radiallycontract structure 611, since the force of member 226 is distributedmore evenly along the curved path of sleeve 26 from the inner wall ofsleeve 26 facing center C, once structure 611 is curved to correspond tothe shape of the annulus.

Additionally, once structure 611 is curved to correspond to the shape ofthe annulus, offsetting portion 614 enables structure to assume aconfiguration in which the entire contraction member 226 is disposedalong an inner perimeter of structure 611 (i.e., facing center C) andnot along any portion of the outer perimeter of structure 611. As such,the configuration prevents entangling of member 226 with any anchor thatis anchored through sleeve 26 at the outer perimeter of structure 611,as described hereinabove, for example, with reference to FIGS. 3A-G and4A-B.

It is to be noted that the coupling of member 226 to sleeve 26 ofstructure 611 in the helical orientation such that member 226 definesportions 612, 614, and 616, may be applied to any annuloplasty structure222 described herein. Additionally, it is to be noted that any systemdescribed herein for use with annuloplasty structure 222 may be used incombination with annuloplasty structure 611.

Reference is now made to FIGS. 22A-C, which are schematic illustrationsof a system 620 comprising an implant configured for delivery into aheart of a subject, in accordance with some applications of the presentinvention. The implant comprises annuloplasty ring structure 222 (i.e.,an implant, e.g., an annuloplasty band) comprising flexible sleeve 26(as described hereinabove with reference to FIG. 1) defining a primarybody portion 750 of structure 222.

FIG. 22A is similar to FIG. 20, as described hereinabove, with theexception that sleeve 26 of structure 222 is shown as being twisted evenmore than sleeve 26 of FIG. 20 such that a portion of contraction member226 is disposed on the underside of structure 222 once structure 222 iscurved to correspond to the curved shape of annulus 240. In such amanner, during anchoring of anchors 32 through the portion of sleeve 26that is twisted, it is possible that anchors 32 can entangle with theportion of contraction member 226 that is disposed adjacent to thetissue of annulus 240. Additionally, in the twisted state of sleeve 26,contraction member 226 is not uniformly and consistently disposed alongthe inner wall of sleeve 26 facing center C, once structure 222 iscurved to correspond to the shape of the annulus. As will be describedhereinbelow with reference to FIGS. 22B-C, in order to prevent anyportion of contraction member 226 being disposed adjacent the tissue ofthe annulus which is shown in FIG. 22A, prior to delivery of structure222, sleeve 26 is actively twisted around a central longitudinal axis Aof channel 18 disposed within sleeve 26 and when sleeve 26 assumes alinear shape and/or structure 222 is rotated around axis A.

Typically, second end 429 of contraction member 226 (i.e., the end notcoupled to adjustment mechanism 40) is fixedly coupled to sleeve 26(e.g., using a crimp bead, as shown). As shown in FIG. 22A, in the upperimage, in a resting state of structure 222, second end 429 ofcontraction member 226 is at a distance of between 0 and 0.25 radiansfrom a location 624 along sleeve 26 at which contraction member 226exits away from sleeve 26 and to adjustment mechanism 40. In the restingstate, as shown in the upper image of FIG. 22A, an angle of twistbetween second end 429 of contraction member 226 and location 624 isbetween 0 and 10 degrees.

FIG. 22B shows structure 222 being actively twisted about longitudinalaxis A of channel 18. In the twisted state, as shown in the upper imageof FIG. 22B, second end 429 of contraction member 226 is at a distanceof between 2.5 and 3.5 radians from location 624 along sleeve 26 atwhich contraction member 226 exits away from sleeve 26 and to adjustmentmechanism 40. In the twisted state, as shown in the upper image of FIG.22B, an angle of twist between second end 429 of contraction member 226and location 624 is between 170 and 190 degrees, e.g., 180 degrees.

As described throughout the application, and specifically, hereinabovewith reference to FIGS. 1-2, structure 222 is advanced within catheter14. Channel 18 is disposed within the lumen of structure 222. As shownin FIGS. 22B-C, structure 222 comprises flexible sleeve 26 that definesa lumen having a proximal end, a distal end, and a central longitudinalaxis therebetween. Structure 222 is longitudinally slidable throughcatheter 14 while sleeve 26 is twisted about the axis of sleeve 26 andabout axis A of channel 18. Channel 18 is longitudinally slidablethrough catheter 14 while flexible sleeve 26 of the structure 222encases a distal portion of channel 18 while twisted about the axis ofthe sleeve. Structure 222 is longitudinally slidable through catheter 14with channel 18, while sleeve 26 encases the distal portion of channel18 while sleeve 26 twisted about the axis of sleeve 26.

For some applications of the present invention, sleeve 26 is twistedsuch that an angle of twist between the proximal end and the distal endis 170-190 degrees, e.g., 180 degrees. That is, adjustment mechanism 40is twisted from second end 429 of contraction member 226 at an angle oftwist between 140-180 degrees, e.g., between 155 and 175 degrees.

During the placement of sleeve 26 around annulus 240, successiveportions of sleeve 26 are progressively released off channel 18, asdescribed hereinabove. As the successive portions of sleeve 26 arereleased off channel 18, the angle of twist of sleeve 26 naturally andpassively becomes reduced in a manner in which contraction member 226 isdisposed facing center C of valve 230.

Additionally, once structure 222 is curved to correspond to the shape ofthe annulus, as shown in the lower image of FIG. 22B, the activetwisting of sleeve 26 prior to delivery followed by the reducing of theangle of twist during the releasing of sleeve 26, enables structure 222to assume a configuration in which the entire contraction member 226 isdisposed along an inner perimeter of structure 222 (i.e., facing centerC) and not along any portion of the outer perimeter of structure 222. Assuch, the configuration prevents entangling of member 226 with anyanchor that is anchored through sleeve 26 at the outer perimeter ofstructure 222, as described hereinabove, for example, with reference toFIGS. 3A-G and 4A-B.

FIG. 22C shows structure 222 being rotated around central longitudinalaxis A of channel 18 while sleeve 26 is twisted, as describedhereinabove with reference to FIG. 22B. When structure 222 is rotatedaround central longitudinal axis of channel 18 in a first rotationaldirection as indicated by arrow 622, and when the distal end of sleeve26 is distal to a distal end of catheter 14, adjustment mechanism 40adjacent a first location of sleeve 26 corresponding to a first pointalong a perimeter of a distal end of channel 18, as shown in the upperimage of FIG. 22C.

Additionally, once structure 222 is curved to correspond to the shape ofthe annulus, the rotating of sleeve 26 prior to delivery followed by thereducing of the angle of twist during the releasing of sleeve 26,enables structure 222 to assume a configuration in which the entirecontraction member 226 is disposed along an inner perimeter of structure222 (i.e., facing center C) and not along any portion of the outerperimeter of structure 222. As such, the configuration preventsentangling of member 226 with any anchor that is anchored through sleeve26 at the outer perimeter of structure 222, as described hereinabove,for example, with reference to FIGS. 3A-G and 4A-B.

Reference is now made to FIGS. 22B-C. For some applications of thepresent invention, only sleeve 26 is twisted about axis A, as shown inFIG. 22B while structure 222 is not rotated around axis A as shown inFIG. 22C. For some applications of the present invention, sleeve 26 istwisted about axis A, as shown in FIG. 22B and structure 222 is rotatedaround axis A as shown in FIG. 22C.

Reference is now made to FIGS. 21 and 22A-C. It is to be noted thatstructure 611 described hereinabove with reference to FIG. 21 may beused in place of structure 222 shown in FIGS. 22A-C.

Reference is now made to FIGS. 23A-B, which are schematic illustrationsof a system 630 comprising an implant configured for delivery into aheart of a subject, in accordance with some applications of the presentinvention. The implant comprises annuloplasty ring structure 631 (i.e.,an implant, e.g., an annuloplasty band) comprising a flexible sleeve 26.It is to be noted that annuloplasty structure 631 is similar tostructure 611 as described hereinabove with reference to FIG. 21, withthe exception of structure 631 comprising acontraction-member-protecting element 633. Sleeve 26 defines a primarybody portion 750 of annuloplasty structure 631.

Contraction member 226 defines (1) a first portion 6331 that extendsalong a contracting portion of sleeve 26 and extends away from sleeve 26at a connection point 635, and (2) a second portion 6332 which extendsaway from sleeve 26 and to adjustment mechanism 40.Contraction-member-protecting element 633 protects second portion of6332 since portion 6332 is disposed outside of wall 253 of sleeve 26 andaway from sleeve 26. Additionally, element 633 provides a path alongwhich portion 6332 slides during the tensioning and pulling ofcontraction member 226. This path provided by element 633 preventsentangling of portion 6332 during the tensioning and pulling ofcontraction member 226.

Additionally, contraction-member-protecting element 633 protects secondportion of 6332 from any tool that is placed in proximity of theimplant. In particular, contraction-member-protecting element 633protects second portion of 6332 by at least mostly covering portion6332.

As shown in FIGS. 23A-B, contraction-member-protecting element 633comprises a contraction-member-protecting element sleeve 634 defining alumen therethrough, and second portion 6332 of contraction member 226 isdisposed within the secondary lumen and extends to adjustment mechanism40. Thus, sleeve 26 of structure 631 defines a primary sleeve 637, whilecontraction-member-protecting element sleeve 634 defines a secondarysleeve 639 defining a secondary lumen therethrough, and second portion6332 of contraction member 226 is disposed within the secondary lumen ofsecondary sleeve 639 and extends to adjustment mechanism 40. Secondarysleeve 639 functions as a connector to couple adjustment mechanism 40 toprimary sleeve 637 of structure 631.

For some applications of the present invention, secondary sleeve 639functions as connector 27 described hereinabove with reference to FIG.1.

For some applications of the present invention, sleeve 634 comprises thesame material as sleeve 26, as described hereinabove with reference toFIG. 1. For some applications of the present invention, sleeve 634covers adjustment mechanism 40. For some applications of the presentinvention, the sleeve 26, sleeve 634, and the fabric covering adjustmentmechanism 40 are fabricated from the same material. For someapplications of the present invention, the sleeve 26, sleeve 634, andthe fabric covering adjustment mechanism 40 are fabricated from a singlepiece (i.e., structure 631 is entirely encased in fabric except for theproximal opening in sleeve 26).

Contraction-member-protecting element 633 has (1) a first end that iscoupled to a primary body portion 750 (i.e., sleeve 26) of the structure631, and (2) a second end that is coupled to adjustment mechanism 40.Contraction member 226 extends from adjustment mechanism 40 viacontraction-member-protecting element to primary body portion 750 (i.e.,sleeve 26) of structure 631. Contraction member 226 enters sleeve 26 atconnection point 635, then continues to extend along a contractingportion of sleeve 26. That is, structure 631 defines a contractingportion of structure 631 (i.e., the portion of sleeve along which afirst portion 6331 of contraction member 226 extends) and anon-contracting portion 6333 (i.e., the part of sleeve 26 along whichcontraction member 226 does not extend). Typically the non-contractingportion of sleeve 26 comprises the portion of sleeve 26 that is distalto connection point 635 and extends to distal end wall 251. Typically,connection point 635 is at least 10 mm, e.g., at least 15 mm, from anyend of structure 631, e.g., connection point 635 is at least 10 mm,e.g., at least 15 mm, from end wall 251. That is, typically, the firstend of contraction-member-protecting element 633 is connected to theannuloplasty structure at connection point 635 that is at least 10 mm,e.g., at least 15 mm, from any end of the annuloplasty structure, e.g.,from end wall 251, as shown. For some applications of the presentinvention, connection point 635 is 10-15 mm from end wall 251.

Reference is now made to FIGS. 3A-B and 23A-B. As shown in FIG. 3A,adjustment mechanism 40 advances toward the annulus of the mitral valvedistally to the distal end of sleeve 26. In this way, adjustmentmechanism 40 is disposed on the longitudinal axis of sleeve 26 (e.g.,collinearly with the sleeve), so as to advantageously maintain a smallcross-sectional diameter of the implant for transluminal delivery. InFIG. 3B, subsequent to exposure of at least adjustment mechanism 40 (andtypically at least end wall 251 of sleeve 26) from catheter 14, theadjustment mechanism is moved away from end wall 251. As shown in FIGS.23A-B, contraction-member-protecting element 633 facilitates thismovement of adjustment mechanism 40 by making mechanism 40 flexiblyand/or articulatably coupled to sleeve 26. For some applications,element 633 is tensioned or relaxed to move mechanism 40 with respect tosleeve 26 to reposition mechanism 40. For some applications, guidemember 86 is tensioned or relaxed in order to reposition mechanism 40.

Element 633 is connected to sleeve 26 at connection point 635 in orderto enable portion 6333 of sleeve 26 to be free of contraction member 226for a length L45 of between 10-15 mm of portion 6333. That is, duringdelivery of the annuloplasty structure, mechanism 40 is disposedmost-distally followed by portion 6333 which does not have anycontraction member 226 threaded therethrough. During delivery, element633 is disposed alongside portion 6333. Thus, L4 is slightly larger thanL45. Once the annuloplasty structure has been contracted, as shown inFIG. 23B, adjustment mechanism 40 is brought adjacent to the outersurface of sleeve 26 at connection point 635.

Contraction-member-protecting element 633 has a longitudinal length L4of 10-15 mm prior to the tensioning of contraction member 226 whenmeasured along a central longitudinal axis ofcontraction-member-protecting element 633. As described herein above,prior to adjusting of structure 631 by adjustment mechanism 40,structure 631 is advanced through catheter 12. As structure 631 isadvanced through catheter 12, in a delivery state of structure 631,adjustment mechanism 40 is disposed distal to (i.e., in front of) sleeve26. This configuration is shown in FIG. 3A, which shows the distal partof sleeve 26 and adjustment mechanism 40 disposed distal to the distalpart of sleeve 26 immediately following deployment from catheter 12 andexposed from catheter 14, although this configuration is maintainedthroughout advancement of sleeve 26 and mechanism 40 through catheter 12in the delivery state of the annuloplasty structure. In this deliverystate, contraction-member-protecting element 633 extends from connectionpoint 635 alongside a portion of wall 253 of sleeve 26 to adjustmentmechanism 40 disposed distal to sleeve 26. In this way, adjustmentmechanism 40 is disposed on the central longitudinal axis of sleeve 26(e.g., collinearly with the sleeve), so as to advantageously maintain asmall cross-sectional diameter of the implant for transluminal delivery.

As shown in FIG. 3A, a distal-most portion of contraction member 226 isdisposed distally to the distal end of guide catheter 14 (i.e., a tube)at a first distance from the distal end of the catheter 14, and aportion (i.e., a distal portion) adjustment mechanism 40 is disposeddistally to contraction member 226 at a second distance from the distalend of catheter 14 that is greater than the first distance. Duringinitial deployment of catheter 12 from within catheter 12 (i.e., atube), a distal-most portion of contraction member 226 is disposeddistally to the distal end of guide catheter 12 (i.e., a tube) at afirst distance from the distal end of the catheter 12, and a portion(i.e., a distal portion) adjustment mechanism 40 is disposed distally tocontraction member 226 at a second distance from the distal end ofcatheter 12 that is greater than the first distance. That is, during theinitial deployment of catheter 14 from within catheter 12, a portion ofadjustment mechanism 40 (e.g., a distal portion) is disposed distally tothe distal end of catheter 12 while contraction member 226 is disposedentirely within catheter 12.

Reference is now made to FIGS. 3B and 23A. Once a distal portion ofsleeve 26 is deployed within the atrium of the heart, adjustmentmechanism 40 is movable away from body portion 750 and distanced fromsleeve 26 (i.e., body portion 750 of structure 631) by a distance of10-15 mm, e.g., 10 mm, which corresponds to longitudinal length L4, asshown in FIG. 23A. Typically, adjustment mechanism 40 is distanced fromthe sleeve via second portion 6332 of contraction member 226 and/or asshown, adjustment mechanism 40 is distanced from the sleeve viacontraction-member-protecting element 633.

As shown in FIG. 23B, subsequently to the deploying of the distalportion of sleeve 26, structure 631 assumes a deployed state in whichmechanism 40 moves closer to connection point 635 and the distancebetween adjustment mechanism 40 and the body portion 750 of structure631 (i.e., sleeve 26) is reduced by actuating adjustment mechanism 40and adjusting the tension of contraction member 226, as shown in FIG.23B.

As adjustment mechanism 40 is actuated, tension is applied tocontraction member 226 as successive portions of member 226 are woundaround the spool of mechanism 40. Responsively to the tensioning ofmember 226, successive portions of primary sleeve 637 contract. Onceprimary sleeve 637 contracts, secondary sleeve 639 (i.e.,contraction-member-protecting element 633) contracts and changes shapeas tension is applied to second portion 6332 of contraction member 226.During tensioning of second portion 6332 of contraction member 226,contraction-member-protecting element 633 protects second portion 6332of contraction member 226.

During the reducing of the distance between adjustment mechanism 40, alength of contraction-member-protecting element 633 is reduced and ashape of contraction-member-protecting element 633 changes. As shown inFIG. 23, contraction-member-protecting element 633 is brought closer towall 253 of sleeve 26 while being compressed and/or folded, and aportion of element 633 is pressed against wall 253 of sleeve 26 ofstructure 631. That is, at least a portion of element 633 is pressedagainst wall 253 of sleeve 26 and element 633 has a pressed longitudinallength L44 of 0.5-1.5 mm, e.g., 1 mm, measured along the longitudinalaxis of element 633. As shown in FIG. 23B, the distance betweenadjustment mechanism 40 and sleeve 26 is smaller than the distancebetween adjustment mechanism 40 and sleeve 26 corresponding to length L4shown in FIG. 23A, prior to actuation of adjustment mechanism 40.

As shown in FIG. 23B, once structure 631 is in the deployed state, aplurality of tissue anchors 32 are used to anchor structure 631 toannulus 240. The plurality of tissue anchors 32 comprises (i) at leastthree tissue anchors 32 disposed at the distal portion of structure 631(i.e., at non-contracting portion 6333), and (ii) at least one tissueanchor 32 (e.g., a plurality, as shown) is disposed in the contractingportion of structure 631 (i.e., the portion of sleeve along which afirst portion 6331 of contraction member 226 extends).

For some applications of the present invention, adjustment mechanism 40is surrounded by a sheath 636 that is an extension of secondary sleeve639.

Reference is again made to FIGS. 23A-B. For some applications,contraction-member-protecting element 633 comprises a radiopaquematerial which functions as an adjustment indicator 632 which providesan indication of the adjustment of contraction member 226 and of theannuloplasty structure. For some applications of the present invention,adjustment indicator 632 functions as a tension indicator which providesan indication of the tension of contraction member 226 and of theannuloplasty structure. As element 633 changes shape according to anincrease or a decrease in a degree of tension of contraction member 226(i.e., portion 6332 passing through sleeve 639), the radiopaque materialin element 633 enables element 633 to function as indicator 632. Asshown in FIG. 23B, a portion of indicator 632 is pressed against sleeve26 of structure 631.

Adjustment indicator 632 is typically coupled to a body portion 750 ofthe implant, for some applications of the present invention. Forexample, the implant comprises an annuloplasty ring structure having abody portion 750 (e.g., sleeve 26), and indicator 632 is directlycoupled to the body portion 750 of the annuloplasty ring structure. Asshown, indicator 632 is directly coupled to an external surface of thebody portion 750 of the annuloplasty ring structure.

It is to be noted that contraction-member-protecting element 633 may beused in combination with any annuloplasty structure described herein(e.g., structures 222, 611, or any other annuloplasty structuredescribed hereinbelow). It is to be noted that for some applications ofthe present invention, annuloplasty structures described herein may beprovided with or without contraction-member-protecting element 633.

Reference is now made to FIGS. 24A-B, which are schematic illustrationsof a system 640 comprising an implant configured for delivery into aheart of a subject, in accordance with some applications of the presentinvention. The implant comprises annuloplasty ring structure 641 (i.e.,an implant, e.g., an annuloplasty band) comprising a flexible sleeve 26.It is to be noted that annuloplasty structure 641 is similar tostructure 631 as described hereinabove with reference to FIGS. 23A-B,with the exception of structure 641 comprising a spring 642. Sleeve 26defines a primary body portion 750 of annuloplasty structure 641.

Spring 642 is shaped so as to define a lumen which surrounds secondportion 6332 of contraction member 226. For some applications, secondportion 6332 extends alongside spring 642. Spring 642 is disposed withincontraction-member-protecting element sleeve 634. For some applicationsof the present invention, spring 642 comprises a telescoping spring,e.g., a volute spring, as shown. It is to be noted that any suitablespring may be positioned within contraction-member-protecting elementsleeve 634. For example, a helical spring may be positioned withincontraction-member-protecting element sleeve 634.

For some applications of the present invention, spring 642 comprises aradiopaque material such that contraction-member-protecting element 633functions as adjustment indicator 632. Adjustment indicator 632 istypically coupled to a body portion of the implant, for someapplications of the present invention. For example, the implantcomprises an annuloplasty ring structure having a body portion (e.g.,sleeve 26), and indicator 632 is directly coupled to the body portion ofthe annuloplasty ring structure. As shown, indicator 632 is directlycoupled to an external surface of the body portion of the annuloplastyring structure.

During the reducing of the distance between adjustment mechanism 40 andsleeve 26, as described hereinabove with reference to FIGS. 23A-B, thelength of contraction-member-protecting element 633 is reduced and ashape of contraction-member-protecting element 633 changes. That is,during the reducing of the distance between adjustment mechanism 40 andsleeve 26, spring 642 compresses, as shown in FIG. 24B. During thecompressing of spring 642, a shape of spring 642 changes, and thus, theradiopaque material of spring 642 provides an indication of contractionof structure 641. That is, in response to an increase in the degree oftension of contraction member 226 the shape of the radiopaque element ofspring 642 changes by compressing spring 642. As shown in FIG. 24B, aportion of indicator 632 is pressed against sleeve 26 of structure 641.

It is to be noted that contraction-member-protecting element 633 and/orspring 642 may be used in combination with any annuloplasty structuredescribed herein (e.g., structures 222, 611, 631, or any otherannuloplasty structure described hereinbelow). It is to be noted thatfor some applications of the present invention, annuloplasty structuresdescribed herein may be provided with or withoutcontraction-member-protecting element 633.

Reference is now made to FIGS. 25A-B, which are schematic illustrationsof a system 640 comprising an implant configured for delivery into aheart of a subject, in accordance with some applications of the presentinvention. The implant comprises annuloplasty ring structure 651 (i.e.,an implant, e.g., an annuloplasty band) comprising a flexible sleeve 26.It is to be noted that annuloplasty structure 651 is similar tostructure 631 as described hereinabove with reference to FIGS. 23A-B,with the exception of structure 651 comprising a band 654. Sleeve 26defines a primary body portion 750 of annuloplasty structure 641.

Band 654 defines contraction-member-protecting element 633 since secondportion 6332 of contraction member 226 is woven, e.g., threaded, throughband 654, and thereby band 654 protects portion 6332 of contractionmember 226 and prevents interference of portion 6332 with actuation ofadjustment mechanism 40. FIG. 25A shows structure 651 before contractionmember 226 is fully pulled tight. In such a state, second portion 6332is not pulled tight and band 654 is in a relaxed state and is notpressed against sleeve 26 (i.e., it is in an unpressed state). In therelaxed, unpressed state, band 654 defines a longitudinal length L4 of10-15 mm measured along a longitudinal axis of the band, a width W3 of3-5 mm, and a thickness of 0.1-0.3 mm. Typically, width W3 of band 654is 10 times greater than a width of contraction member 226.

In the relaxed, unpressed state of band 654, adjustment mechanism 40 isdistanced from sleeve 26 (i.e., the body portion of structure 631) by adistance of 10-15 mm which corresponds to longitudinal length L4, asshown in FIG. 25A. Typically, adjustment mechanism 40 is distanced fromsleeve 26 via second portion 6332 of contraction member 226 and/or asshown, adjustment mechanism 40 is distanced from sleeve 26 via band 654of contraction-member-protecting element 633.

For some applications of the present invention,contraction-member-protecting element 633 comprises a strip whichfunctions as band 654.

When contraction member 226 is fully pulled tight by adjustmentmechanism 40 (i.e., when there is an increase in the degree of tensionof member 226), band 654 changes shape (e.g., compresses and/or isfolded, as shown in FIG. 25B), in order to bring adjustment mechanism 40closer to wall 253 of sleeve 26. During the pulling of contractionmember 226, portion 6332 slides along the length of band 654 whichprotects and provides a path for the sliding of portion 6332 ofcontraction member 226 during the sliding of portion 6332 along band654. Additionally, band 654 prevents entangling of portion 6332 duringthe pulling of contraction member 226.

During the pulling of contraction member 226, and the sliding of portion6332 along band 654, at least a portion of band 654 is pressed againstwall 253 of sleeve 26 and band 654 has a pressed longitudinal length L44of 0.5-1.5 mm, e.g., 1 mm, measured along the longitudinal axis of band654.

For some applications of the present invention, band 654 comprises thesame material as sleeve 26, as described hereinabove with reference toFIG. 1. For some applications band 654 of contraction-member-protectingelement 633 comprises a radiopaque material which functions as anadjustment indicator 632 which provides an indication of the adjustmentof structure 651. As element 633 changes shape according to an increaseor decrease in the degree of tension of contraction member 226 (i.e.,portion 6332 passing along band 654), the radiopaque material in element633 enables element 633 to function as indicator 632. As shown in FIG.25B, a portion of indicator 632 is pressed against sleeve 26 ofstructure 651.

Adjustment indicator 632 is typically coupled to a body portion of theimplant, for some applications of the present invention. For example,the implant comprises an annuloplasty ring structure having a bodyportion (e.g., sleeve 26), and indicator 632 is directly coupled to thebody portion of the annuloplasty ring structure. As shown, indicator 632is directly coupled to an external surface of the body portion of theannuloplasty ring structure.

It is to be noted that band 654 may be used in combination with anyannuloplasty structure described herein (e.g., structures 222, 611, 631,641, or any other annuloplasty structure described hereinbelow).

Reference is now made to FIGS. 23A-25B, which show adjustment mechanism40 being coupled to contraction member 226 at a first end portion ofcontraction member 226, and indicator 632 being coupled to contractionmember 226 at a second portion 6332 of contraction member 226. In FIGS.23A-25B, second portion 6332 is adjacent to adjustment mechanism 40 suchthat indicator 632 and the radiopaque material are disposed adjacent toadjustment mechanism 40.

Reference is now made to FIGS. 26A-B, which are schematic illustrationsof a system 660 comprising an annuloplasty structure 662 comprisingadjustment indicator 632 which comprises an adjustment-indicator band666, in accordance with some applications of the present invention. Itis to be noted that structure 662 is similar to structure 222 describedherein with the exception that structure 662 comprises band 666. Band666 typically comprises a flexible material such as polyester andradiopaque material and provides an indication of contraction ofcontraction member 226 and of structure 662 in general. A portion ofcontraction member 226 adjacent end 429 of member 226 is threadedthrough band 666. That is, as shown in FIGS. 26A-B, adjustment mechanism40 is coupled to contraction member 226 at a first end portion ofcontraction member 226, and indicator 632 is coupled to contractionmember 226 at a second end portion of contraction member 226. Sleeve 26defines a primary body portion 750 of structure 222.

Band 666 has a width W22 of 1-5 mm, e.g., 3 mm, and a thickness of0.1-0.5 mm.

For some applications of the present invention, adjustment-indicatorband 666 comprises a strip.

Adjustment indicator 632 is typically coupled to a body portion of theimplant, for some applications of the present invention. For example,the implant comprises an annuloplasty ring structure having a bodyportion (e.g., sleeve 26), and indicator 632 is directly coupled to thebody portion of the annuloplasty ring structure. As shown, indicator 632is directly coupled to an external surface of the body portion of theannuloplasty ring structure.

FIG. 26A shows structure 662 before contraction member 226 is pulledtight. In such a state, band 666 is in a relaxed state and is notpressed against sleeve 26 (i.e., it is in an unpressed state). In therelaxed, unpressed state, band 666 defines a longitudinal length L2 of4-6 mm measured along a longitudinal axis of band 666 from a first endof band 666 to a second end of band 666. In the relaxed, unpressed stateof band 666, an upper portion of band 666, e.g., the apex of band 666,is distanced from sleeve 26 (i.e., the body portion of structure 662) bya distance Di3 of 2-4 mm.

As shown in FIG. 26B, when contraction member 226 is fully pulled tightby adjustment mechanism 40 (i.e., when there is an increase in thedegree of tension of member 226), band 666 changes shape. That is, band666 is flattened and at least a portion of band 666 is pressed closer toand against sleeve 26. During the flattening of band 666, as at least aportion of band 666 is pressed against sleeve 26, band 666 has aflattened, and pressed longitudinal length L3 of 7-10 mm measured alongthe longitudinal axis of band 666 from a first end of band 666 to asecond end of band 666. In the flattened, pressed state of band 666, theupper portion of band 666, e.g., the apex of band 666, is closer tosleeve 26 (i.e., the body portion of structure 662) by a distance Di4 of0-1 mm.

It is to be noted that adjustment-indicator band 666 may be used incombination with any annuloplasty structure described herein (e.g.,structures 222, 611, 631, 641, 651, 711, 721, or any other annuloplastystructure described hereinbelow).

Reference is now made to FIGS. 27A-B, which are schematic illustrationsof a system 670 comprising an annuloplasty structure 672, in accordancewith some applications of the present invention. It is to be noted thatstructure 672 is similar to structure 222 described herein with theexception that structure 672 comprises adjustment indicator 632 whichcomprises a shape-deforming element 674 which comprises first and secondarms 676. Element 674 typically comprises a flexible material such asstainless steel and comprises radiopaque material and provides anindication of contraction of contraction member 226 and of structure 672in general. A portion of contraction member 226 adjacent end 429 ofmember 226 is coupled to element 674. That is respective portions ofmember 226 are coupled to (e.g., threaded through) each of arms 676 ofelement 674. That is, as shown in FIGS. 27A-B, adjustment mechanism 40is coupled to contraction member 226 at a first end portion ofcontraction member 226, and indicator 632 is coupled to contractionmember 226 at a second end portion of contraction member 226. Sleeve 26defines a primary body portion 750 of structure 672.

Adjustment indicator 632 is typically coupled to a body portion of theimplant, for some applications of the present invention. For example,the implant comprises an annuloplasty ring structure having a bodyportion (e.g., sleeve 26), and indicator 632 is directly coupled to thebody portion of the annuloplasty ring structure. As shown, indicator 632is directly coupled to an external surface of the body portion of theannuloplasty ring structure.

FIG. 27A shows structure 672 before contraction member 226 is pulledtight. In such a state, and element 674 is in a relaxed state and arms676 are spaced apart from each other.

As shown in FIG. 27B, when contraction member 226 is fully pulled tightby adjustment mechanism 40 (i.e., when there is an increase in thedegree of tension of member 226), element 674 changes shape in order tochange a distance between first and second arms 676. That is, arms 676are pulled closer toward each other and a distance between arms 676 isreduced. Conversely, when tension of contraction member 226 is reduced,tension on arms 676 is reduced and arms 676 are drawn away from eachother and return to their resting state.

It is to be noted that shape-deforming element 674 may be used incombination with any annuloplasty structure described herein (e.g.,structures 222, 611, 631, 641, 651, 711, 721, or any other annuloplastystructure described hereinbelow).

Reference is now made to FIGS. 28A-B, which are schematic illustrationsof a system 680 comprising an annuloplasty structure 682, in accordancewith some applications of the present invention. It is to be noted thatstructure 682 is similar to structure 222 described herein with theexception that structure comprises adjustment indicator 632 whichcomprises a receptacle 684 and a plug 686. Receptacle 684 is coupled toan outer surface of sleeve 26. Receptacle 684 and plug 686 compriseradiopaque material and provides an indication of contraction ofcontraction member 226 and of structure 682 in general. A portion ofcontraction member 226 adjacent end 429 of member 226 is coupled to plug686. That is, as shown in FIGS. 28A-B, adjustment mechanism 40 iscoupled to contraction member 226 at a first end portion of contractionmember 226, and indicator 632 is coupled to contraction member 226 at asecond end portion of contraction member 226. Sleeve 26 defines aprimary body portion 750 of structure 682.

FIG. 28A shows structure 682 before contraction member 226 is pulledtight. In such a state, at least a majority of plug 686 is disposedoutside of a space defined by receptacle 684.

As shown in FIG. 28B, when contraction member 226 is fully pulled tightby adjustment mechanism 40 (i.e., when there is an increase in thedegree of tension of member 226), indicator 632 changes shape in orderto position and fit plug 686 within the space defined by receptacle 684.Conversely, when tension of contraction member 226 is reduced, plug 686is moved away from the space defined by receptacle 684.

Adjustment indicator 632 is typically coupled to a body portion of theimplant, for some applications of the present invention. For example,the implant comprises an annuloplasty ring structure having a bodyportion (e.g., sleeve 26), and indicator 632 (e.g., at least receptacle684) is directly coupled to the body portion of the annuloplasty ringstructure. As shown, indicator 632 (e.g., at least receptacle 684) isdirectly coupled to an external surface of the body portion of theannuloplasty ring structure.

It is to be noted that receptacle 684 and plug 686 may be used incombination with any annuloplasty structure described herein (e.g.,structures 222, 611, 631, 641, 651, 711, 721, or any other annuloplastystructure described hereinbelow).

Reference is now made to FIGS. 29A-B, which are schematic illustrationsof a system 690 comprising an annuloplasty structure 692 comprisingadjustment indicator 632 which comprises an adjustment-indicator spring694, in accordance with some applications of the present invention. Itis to be noted that structure 692 is similar to structure 222 describedherein with the exception that structure 692 comprises spring 694.Spring 694 typically comprises a flexible material such as stainlesssteel and radiopaque material and provides an indication of contractionof contraction member 226 and of structure 692 in general. For someapplications, spring 694 comprises a folded spring with peaks andvalley, as shown in FIGS. 29A-B. For some applications, spring 694comprises a helical spring. For some applications, spring 694 comprisesa telescoping spring, e.g., a volute spring or any other telescopingspring. Sleeve 26 defines a primary body portion 750 of structure 692.

A portion of contraction member 226 adjacent end 429 of member 226 iscoupled to one end of spring 694. A second end of spring 694 comprises asleeve coupler 696 which fixedly couples the second end of spring 694 tosleeve 26. As shown in FIGS. 29A-B, adjustment mechanism 40 is coupledto contraction member 226 at a first end portion of contraction member226, and indicator 632 is coupled to contraction member 226 at a secondend portion of contraction member 226.

FIG. 29A shows structure 662 before contraction member 226 is pulledtight. In such a state, spring 694 is in a relaxed, unpulled state. Inthe relaxed, unpulled state, spring 694 defines a longitudinal length L5of 2-4 mm measured along a longitudinal axis of spring 694 from thefirst end of spring 694 to a second end of spring 694 before coupler696.

As shown in FIG. 29B, when contraction member 226 is fully pulled tightby adjustment mechanism 40 (i.e., when there is an increase in thedegree of tension of member 226), spring 694 changes shape. That is,spring 694 is pulled longitudinally and is stretched. During the pullingof spring 694, spring 694 has a pulled longitudinal length L5 of 6-8 mmmeasured along the longitudinal axis of spring 694 from the first end ofspring 694 to the second end of spring 694 before coupler 696. For someapplications of the present invention, markers 25 are used as referencepoints for how far spring 694 is pulled.

Adjustment indicator 632 is typically coupled to a body portion of theimplant, for some applications of the present invention. For example,the implant comprises an annuloplasty ring structure having a bodyportion (e.g., sleeve 26), and indicator 632 is directly coupled to thebody portion of the annuloplasty ring structure. As shown, indicator 632is directly coupled to an external surface of the body portion of theannuloplasty ring structure.

It is to be noted that adjustment-indicator spring 694 may be used incombination with any annuloplasty structure described herein (e.g.,structures 222, 611, 631, 641, 651, 711, or 721).

Reference is now made to FIG. 30, which is a schematic illustration of asystem 700 comprising an implant configured for delivery into a heart ofa subject, in accordance with some applications of the presentinvention. The implant comprises an annuloplasty ring structure 711(i.e., an implant, e.g., an annuloplasty band) comprising flexiblesleeve 26 and an adjustment mechanism 40 (as described hereinabove withregard to structure 222, with reference to FIG. 1).

Structure 711 is similar to structure 222 with the exception thatcontraction member 226 is coupled to sleeve 26 in a manner in which atleast a part of contraction member 226 is disposed helically aroundlongitudinal axis A of sleeve 26 of structure 222 in the absence oftorsion or twisting applied to sleeve 26. For some applications, atleast 50%, e.g., at least 60% of contraction member 226 is disposedhelically around axis A. Sleeve 26 defines a primary body portion 750 ofstructure 711. Sleeve 26 has a lateral wall through which contractionmember 226 is woven.

As shown, contraction member 226 extends along first portion 6331 whichdefines the contracting portion of sleeve 26. Contraction member 226extends along at least the contracting portion of sleeve 26 at an angleof twist between a proximal end and a distal end of sleeve 26 that is170-190 degrees, e.g., 180.

As shown in the upper image of FIG. 30, second end 429 of contractionmember 226 is at a distance of between 2.5 and 3.5 radians from location624 along sleeve 26 at which contraction member 226 exits away fromsleeve 26 and to adjustment mechanism 40. An angle of twist betweensecond end 429 of contraction member 226 and location 624 is between 170and 190 degrees, e.g., 180 degrees. That is, adjustment mechanism 40 ispositioned from second end 429 of contraction member 226 at an angle ofbetween 140-180 degrees, e.g., between 155 and 175 degrees from secondend 429 of contraction member 226.

Additionally, once structure 711 is curved to correspond to the shape ofthe annulus, as shown in the lower image of FIG. 30, the helicalcoupling of contraction member 226 to sleeve 26, enables structure 711to assume a configuration in which the entire contraction member 226 isdisposed along an inner perimeter of structure 711 (i.e., facing centerC) and not along any portion of the outer perimeter of structure 711. Assuch, the configuration prevents entangling of member 226 with anyanchor that is anchored through sleeve 26 at the outer perimeter ofstructure 711, as described hereinabove, for example, with reference toFIGS. 3A-G and 4A-B.

Reference is now made to FIGS. 31A-C, which are schematic illustrationsof a system 720 comprising an implant configured for delivery into aheart of a subject, in accordance with some applications of the presentinvention. The implant comprises an annuloplasty ring structure 721(i.e., an implant, e.g., an annuloplasty band) comprising flexiblesleeve 26 and an adjustment mechanism 40 (as described hereinabove withregard to structure 222, with reference to FIG. 1). Sleeve 26 defines aprimary body portion 750 of structure 721.

Structure 711 is similar to structure 651 described hereinabove withreference to FIG. 25, with the exception that sleeve 26 is shaped so asto define first and second holes 723 and 725 in a vicinity ofcontraction-member-protecting element 633. Typically, holes 723 and 725are disposed in a vicinity of connection point 635. A portion ofcontraction member 226 exits sleeve 26 from hole 723 and reenters thelumen of sleeve 26 through hole 725. That is, the portion of contractionmember 226 exits away from primary body portion 750 of structure 721through first hole 723 and reengages primary body portion 750 ofstructure 721 through second hole 725. Typically, second hole 725 isdisposed at a distance L46 of 16-22 mm from end wall 251 of primary bodyportion 750 (e.g., sleeve 26). Typically, holes 723 and 725 are 0.3-0.7mm in diameter.

A majority of contraction member 226 is threaded through sleeve 26 andwoven in and out of the lumen of sleeve 26 through a plurality ofthreading points 722. Threading points 722 are areas of sleeve 26through which contraction member 226 is threaded. In addition tothreading points 722, sleeve 26 defines holes 723 and 725 which arelarger than the openings provided by points 722. That is there is lessfriction between sleeve 26 and contraction member 226 at holes 723 and725 than there is at threading points 722. Thus, structure 721 defines afirst portion 726 having a first degree of friction between primary bodyportion 750 (e.g., sleeve 26) and a first portion of contraction member226, and structure 721 defines a second portion 724 having a seconddegree of friction between primary body portion 750 (e.g., sleeve 26)and a second portion of contraction member 226. The second degree offriction is less than the first. Typically, when contraction member 226is not pulled fully tight as shown in FIGS. 31A-B, second portion 724defines a contraction-member-free section of primary body portion 750(e.g., sleeve 26) that is between first and second holes 723 and 725.

As shown in FIG. 31B, during the placement of sleeve 26 around annulus240, sleeve 26 is curved and sleeve 26 initially passively contracts toconform to the shape of annulus 240. During the initial contraction(i.e., the contraction performed passively in response to placing sleeve26 around annulus 240, and not by actuation of adjustment mechanism 40),the contracted shape of sleeve 26 does not accommodate the length ofcontraction member 226 as it had in its linear state (shown in FIG.31A). As such, a portion of contraction member 226 is forced a bit outoutside of primary body portion 750 (e.g., sleeve 26) through holes 723and 725. Holes 723 and 723 thereby accommodate and encourage themovement of the excess portion of contraction member 226 during thecurving of sleeve 26 responsively to the anchoring of sleeve 26 alongthe annulus, and prior to actuation of adjustment mechanism 40. Holes723 and 725 enable the excess portion of contraction member 226 to exitaway from a surface of the annuloplasty structure at a location of thestructure that is along primary body portion 750 (e.g., sleeve 26) ofthe annuloplasty structure and not at adjustment mechanism 40, which isadvantageous because the excess portion of contraction member 226exiting along primary body portion 750 of the annuloplasty structuretypically does not interfere with the function of the adjustmentmechanism 40.

FIG. 31C shows structure 721 in a fully-contracted state in whichcontraction member 226 is pulled tight even at second portion 724 ofstructure 721 that is between first and second holes 723 and 725.

During the pulling of member 226 responsively to actuation of adjustmentmechanism 40, contraction member 226 slides freely and with minimalfriction through holes 723 and 725 relatively to the sliding ofcontraction member 226 through threading points 722 which occurs withmore friction.

It is to be noted that system 710 may be used in combination with anyannuloplasty structure described herein (e.g., structures 222, 611, 631,641, 651, or 711).

It is to be noted that any of the apparatus or methods described hereinmay be used in combination with those described in PCT applicationpublication WO 2014/064694, which is incorporated herein by reference inits entirety.

The invention claimed is:
 1. A system, for use with a tissue of asubject, the system comprising: an anchor, comprising: an anchor head,and a tissue-engaging member, coupled to the anchor head, extendingdistally away from the anchor head until a distal tip of thetissue-engaging member, and configured to anchor the anchor to thetissue; and an anchor driver, comprising: a longitudinal shaft, having aflexible distal portion and a distal end, a deployment element at thedistal end of the shaft, reversibly lockable to the anchor head, andreversibly movable between (i) a locked state that retains lockingbetween the deployment element and the anchor head, and (ii) an unlockedstate that unlocks the deployment element from the anchor head, and atissue-piercing lance, reversibly movable between: an extended state inwhich (i) the lance extends distally from the shaft, (ii) while thedeployment element is locked to the anchor head, the lance extendsdistally past the distal tip of the tissue-engaging member, and (iii)the lance retains the deployment element in the locked state, and aretracted state in which: the lance does not extend distally from theshaft, and the deployment element automatically moves into the unlockedstate.
 2. The system according to claim 1, wherein in the retractedstate, the lance does not extend distally past the distal tip of thetissue-engaging member.
 3. The system according to claim 1, wherein: thedeployment element comprises one or more detents, in the extended state,the lance holds the detents in a locking position in which the detentsengage the anchor head, and upon movement of the lance into theretracted state, the detents automatically move out of the lockingposition.
 4. The system according to claim 1, wherein the lance has apartly-retracted state in which: the lance retains the deploymentelement in the locked state, and while the deployment element is lockedto the anchor head, the lance does not extend distally past the distaltip of the tissue-engaging member.
 5. The system according to claim 1,wherein the anchor driver comprises a force gauge configured to measuremagnitude of a force applied to tissue at an implant site.
 6. Anapparatus, for use with a tissue of a subject, the apparatus comprising:an anchor, comprising: an anchor head, having a proximal side and adistal side, and defining an aperture from the proximal side to thedistal side, and a tissue-engaging member, coupled to the anchor head,extending distally away from the anchor head until a distal tip of thetissue-engaging member, and configured to anchor the anchor to thetissue; an anchor driver, comprising: a longitudinal shaft, having aflexible distal portion and a distal end, a tissue-piercing lance,reversibly (i) extendible distally from the shaft, and (ii) retractableso as to not extend distally from the shaft, and a deployment elementcoupled to the distal end of the shaft, and reversibly couplable to theanchor head in a position in which extension of the lance distally fromthe shaft moves the lance through the aperture and past the distal tipof the tissue-engaging member; and a catheter system, comprising: acatheter: through which the anchor driver is intracorporeallyadvanceable (i) while the deployment element is coupled to the anchorhead, and (ii) such that the distal portion of the shaft extendsdistally out of the catheter, and having a distal segment that isintracorporeally deflectable with respect to another segment of thecatheter immediately proximal to the distal segment, and anextracorporeal controller configured, while the distal portion of theshaft is extended distally out of the catheter, and the lance isextended distally from the shaft and is disposed in the tissue, to causedeflection of the distal segment with respect to the other segment, suchthat the distal portion of the shaft deflects with respect to anotherportion of the shaft immediately proximal to the distal portion, theanchor driver being configured to drive the tissue-engaging member intothe tissue while the distal portion of the shaft is deflected withrespect to the other portion of the shaft.
 7. The apparatus according toclaim 6, wherein: the deployment element is reversibly movable between(i) a locked state that retains locking between the deployment elementand the anchor head, and (ii) an unlocked state that unlocks thedeployment element from the anchor head, and the lance has: an extendedstate in which the lance extends distally from the shaft, and retainsthe deployment element in the locked state, and a retracted state, thedeployment element being configured to automatically move into theunlocked state upon movement of the lance into the retracted state. 8.The apparatus according to claim 7, wherein: the deployment elementcomprises one or more detents, in the extended state, the lance holdsthe detents in a locking position in which the detents engage the anchorhead, and upon movement of the lance into the retracted state, thedetents automatically move out of the locking position.
 9. The apparatusaccording to claim 7, wherein, while the deployment element is locked tothe anchor head, in the extended state the lance extends distally pastthe distal tip of the tissue-engaging member.
 10. The apparatusaccording to claim 9, wherein the lance has a partly-retracted state inwhich: the lance retains the deployment element in the locked state, andwhile the deployment element is locked to the anchor head, the lancedoes not extend distally past the distal tip of the tissue-engagingmember.
 11. The apparatus according to claim 6, further comprising animplant, wherein the anchor driver is configured: to advance the anchorthrough the catheter to the implant, and into a position in which thelance is extendible out of the implant and into the tissue, and toanchor the implant to the tissue by driving the tissue-engaging memberthrough the implant and into the tissue.
 12. The apparatus according toclaim 11, wherein: the implant comprises a flexible sleeve, and theanchor driver is configured: to advance the anchor into a positioninside the sleeve in which the lance is extendible through a wall of thesleeve and into the tissue, and to anchor the implant to the tissue bydriving the tissue-engaging member through the wall of the sleeve andinto the tissue.
 13. The apparatus according to claim 12, wherein theimplant further comprises a flexible elongated contraction member thatextends along the sleeve, and wherein tensioning of the contractionmember contracts the sleeve.
 14. The apparatus according to claim 13,wherein the implant further comprises an adjustment mechanism, coupledto the sleeve and to the contraction member, and wherein actuation ofthe adjustment mechanism adjusts tension of the contraction member. 15.The apparatus according to claim 14, wherein the adjustment mechanismcomprises a spool, and a housing that houses the spool, the spool beingcoupled to the contraction member such that rotation of the spool withinthe housing adjusts the tension of the contraction member.
 16. Theapparatus according to claim 14, wherein the implant is advanceable tothe tissue while (i) at least the sleeve is disposed within thecatheter, and (ii) the adjustment mechanism is disposed distally fromthe sleeve, in front of a distal end wall of the sleeve.
 17. Theapparatus according to claim 16, wherein the wall of the sleeve is thedistal end wall of the sleeve, and wherein: the anchor driver isconfigured: to advance the anchor into a position inside the sleeve inwhich the lance is extendible through the distal end wall of the sleeveand into the tissue, and to anchor the implant to the tissue by drivingthe tissue-engaging member through the distal end wall of the sleeve andinto the tissue, and the adjustment mechanism is movably coupled to thesleeve, and is movable away from the distal end wall to become disposedlaterally from the sleeve, after advancement of the implant to thetissue, and before advancement of the lance through the distal end wall.18. The apparatus according to claim 14, wherein: the adjustmentmechanism is disposed outside of the sleeve, and wherein the contractionmember extends outside of the sleeve at a connection point and extendsbetween the connection point and the adjustment mechanism, the implantdefines a non-contracting portion of the sleeve, between the connectionpoint and a distal end of the sleeve, the contraction member not beingdisposed in the non-contracting portion, the non-contracting portionbeing 10-15 mm long, and the adjustment mechanism is movable, whilecoupled to the sleeve, between the distal end of the sleeve and theconnection point.
 19. A system, for use with a tissue of a subject, thesystem comprising: an anchor, comprising: an anchor head, and atissue-engaging member coupled to the anchor head and configured toanchor the anchor to tissue; and an anchor driver, comprising: alongitudinal shaft, having a flexible distal portion and a distal end, adeployment element at the distal end of the shaft, releasably coupled tothe anchor head, and a tissue-piercing lance, reversibly movablebetween: an extended state in which the lance extends distally from theshaft, and a retracted state in which the lance is proximal of theextended state and does not extend distally from the shaft.
 20. Thesystem according to claim 19 further configured such that when thetissue-piercing lance transitions to the retracted state, the deploymentelement automatically releases the anchor head.
 21. The system accordingto claim 19, wherein in the extended state, while the deployment elementis locked to the anchor head, the lance extends distally past a distaltip of the anchor, and wherein the lance retains the deployment elementin a locked state coupled to the anchor head.
 22. The system accordingto claim 19, further comprising an implant, wherein the anchor driver isconfigured: to advance the anchor transcatheterally to the implant, andinto a position in which the lance is extendible out of the implant andinto the tissue, and to anchor the implant to the tissue by driving thetissue-engaging member through the implant and into the tissue.
 23. Thesystem according to claim 22, wherein the implant includes at least oneof a volute spring, a contraction-member protecting band, and a primaryand secondary sleeve.
 24. The system according to claim 19, furthercomprising an implant, wherein the anchor driver is configured: toadvance the anchor transcatheterally into a position in which the lanceis extendible into the tissue, and to anchor the implant to the tissueby driving the tissue-engaging member into the tissue.
 25. The systemaccording to claim 24, further comprising an adjustment mechanismactuatable to change a dimension of the implant.
 26. The systemaccording to claim 25, wherein the adjustment mechanism comprises alock, the lock: having a locked state in which the lock inhibitsactuation of the adjustment mechanism, having an unlocked state in whichthe adjustment mechanism is actuatable, and reversibly movable betweenthe locked state and the unlocked state.
 27. The system according toclaim 25, further comprising an adjustment indicator configured toprovide an indication of change of the dimension of the implant uponactuation of the adjustment mechanism.
 28. The system according to claim27, wherein the adjustment indicator comprises at least one of anadjustment-indicator band, a shape-deforming element, a receptacle andplug, and an adjustment indicator spring.
 29. The system according toclaim 19, wherein the anchor driver comprises a force gauge configuredto measure magnitude of a force applied to tissue at an implant site.